VOLAR DISTAL RADIUS FRACTURE SOLUTIONS … DISTAL RADIUS FRACTURE SOLUTIONS Value Analysis Committee Resource Guide Table of Contents About Flower Orthopedics .....1 The FlowerCube

VOLAR DISTAL RADIUS FRACTURE SOLUTIONS

Value Analysis CommitteeResource Guide

Table of ContentsAbout Flower Orthopedics....................................................1The FlowerCube™ ...............................................................2Flower Locking Mechanism...................................................4FlowerBasic™ and FlowerAnatomic™....................................5Distal Radius Fracture Solutions .............................................6510 (k) Clearance Letters .....................................................7

Mr. Oliver Burckhardt and Zrinski AG, Germany founded Flower OrthopedicsCorporation (Flower) in June of 2012. The company was established on thetechnology of the Zrinski Locking Mechanism, invented by Zrinski AG in 2009.

Today, Flower offers eight different FlowerApplications™. Every FlowerApplicationhas implants and instruments needed to cover a range of surgical indications in aspecific anatomical location. All applications are focused on inventory and surgicalcase efficiency to ensure cost savings.

Over the last two years Flower has developed approximately 1,000 implantableproducts, and has created never before seen disposable instruments that comparein high-quality and function to reusable instruments commonly used in the marketplace. Today, Flower’s surgical solutions have been clinically validated byphysicians, ambulatory and acute care facilities. The FlowerCube and the FlowerApplications are consideredthe next logical pathway into a new era of surgical implants and disposable application tools.

Flower Orthopedics is located in Horsham, Pennsylvania, with a nationwide distribution network.

“Our Mission is to eliminateOperating Room Uncertainty and Drive Efficiencies to ensurepredictable patient outcomes while Reducing Overall Case

Expenditure.”

About Flower OrthopedicsAt Flower Orthopedics, we are creating new Standards for Orthopedics by providing cost-effective, safe and efficient, Ready-for-Surgery™ treatment concepts.

Our transformative bone-fixation solutions consist of sterile-packaged implants that featureour patented Flower Locking System. Each implant is matched with our revolutionary, single-use, disposable Flower Instrument Kit.

The Flower Ready-for-Surgery Cube provides complete and standardized surgicalApplications that eliminate the need for pre-op handling and post-op reprocessing. FlowerOrthopedics’ real-world innovations are redefining the protocols and standards forOrthopedics.

At Flower, we focus on cost savings while ensuring clinical excellence.

1

The FlowerCube™ – The NewStandard in Bone Fixation

The FlowerCube is at the heart of everything we do atFlower Orthopedics. Tailored for specific surgicalindications, the FlowerCube houses all of the requisiteimplants and instruments sterile packaged, disposable andalways Ready-for-Surgery™. The FlowerCube is deliveredready for use, eliminating preoperative, on-site sterilization.

2

Within Each FlowerCube you will find the following:

FlowerCarriage™ - The FlowerCarriage contains implants, instruments, andappliances required for a specific bone-fixation surgery. It is made from a sturdyand unique material that allows the surgical team to carry the Carriage, organizedwith all essential application-specific implants and instruments, in and out of thesurgical suite.

Flower Implants - Providing the ultimate in secure bone-fixation, each sterile-packaged, titaniumFlower Implant is designed for a particular indication. Every implant is visible in its package, andthe packages are clearly marked and color coded for simplified handling and easy recognition.QRC codes and bar codes allow for lot tractability.

Flower Trials - Sterile-packaged Flower Trials are included in each cube. The Trials are used topinpoint the exact implant size prior to opening the correct implant box. The laser-marked numberon the removed section of each Trial indicates the correct implant size.

Flower Instrument Kits - All implant-based instruments needed for the procedure are includedin the Instrument Kit. The Ready-for-Surgery instruments provide the added assurance thatthe right surgery-specific tools are in place and in prime condition. Each instrument is sterile,robust, and disposable. There is no need for post-op decontamination.

FlowerCube™: Schedule. Treat. Turn.

3

FlowerCube — Redefining Infection Prevention

FlowerCubes are pre-packaged and ready for use, eliminating costly pre-op sterilization. The instruments are robust,disposable, and new every time, eliminating the traditional wear and tear of instrumentation and post-op decontamination.

The FlowerCube maximizes efficiencies by streamlining and simplifying the ordering process while minimizing inventorylevels and costs.

Turn OR Quicker.(FlowerCube)

Schedule Case Faster.(Ready-for-Surgery™)

Treat Patient Safer.(Sterile & Disposable)

• No cleaning andsterilization

• FlowerCube is alwaysready to complete thecase

• No time consuming setdrop off

• Instrument kits alwayscomplete

• Drill bits always sharp• Guaranteed sterility

• FlowerCube always readyfor the next surgery

• No delay with back to backcases

• Enough sterile inventory formultiple cases

4

Flower Locking MechanismOur patented locking principle is based on a titanium-alloy, polyaxial screw with a bone and locking thread,which is inserted and locked into the FlowerGroove™ of the plate (titanium). By applying a defined torque,the screw head is compressed into the FlowerGroove, which then creates interference that locks the screwhead into the FlowerGroove. The locked angle stability secures the screw in the plate and avoids any potentialfor backwards migration of the screw.

Flower Orthopedics has developed over 400 plates that can be used for various indications. All of the Flowerimplants are manufactured to the highest quality and standards, and all use two standardized locking diameterranges (Flower Small, Flower Medium).

For indications where a Locking Screw is not desired, Flower developed variable angle non-locking screwsthat can be placed in the Flower Locking hole, without engaging the locking mechanism.

Secure Locking at any any angle:

• Variable Angle Screws can be inserted up to ±15° in all directions• Variable Angle Locking Screws are securely locked through the range of insertion angles• FlowerGroove eliminates potential cross-threading • Locking engagement begins at final screw turn • Titanium: Screw, Grade 5; Plate, Grade 2 → produces a robust locking construct• Permanent, yet reversible locking → Surgeon can position locking screw up to 3 times (if necessary)• Torque Limiting Screw Driver provides audible & tactile assurance that construct is locked• FlowerGroove also accepts Variable Angle Non-Locking Screws

5

FlowerBasic™ and FlowerAnatomic™ Flower Orthopedics carries two distinct product lines; FlowerBasic and FlowerAnatomic. Platesin both product lines are made out of grade 2 titanium in Germany, adhering to the strictestmanufacturing guidelines. FlowerBasic plates are for general, and multi-use and include ourextensive line of Recon and Osteosynthesis plates. FlowerAnatomic plates are all anatomicallycountoured, low profile and engineered for specific applications.

Both FlowerBasic and FlowerAnatomic use our standard instrumentation, and are available inpre-built and customized FlowerCubes™.

FlowerBasic

Distal Radius Plates, Volar

Recon Plates (Small, Medium)

Osteosynthesis Plates (Small, Medium)

FlowerAnatomic

Anatomic Distal Radius Plates, Volar

Proximal Humerus Plates

Hand Plates (Small)

Foot Plates (Small, Medium)

Ankle Plates

FlowerBasic: Distal Radius Plates, Volar

The FlowerBasic product lines carries Small (2.0mmthickness) and Medium (2.4mm thickness) Volar Distal Radius Plates. Plates are available inNarrow and Wide, and Left/Right Configurations

• Economical, yet robust plates and instruments• Targeted screw holes provide enhanced fixation • K-Wire holes provide fracture reduction and aid in thecorrect plate placement

• Plate window allows direct visualization, bone graftapplication and fragment manipulation through theplate

• Plate trial templates simplify plate selection and act asbending template

• Streamlined instrumentation provides ease of use withzero learning curve

FlowerAnatomic™: Volar Distal Radius PlateAnatomic fracture reduction and stabilization can beachieved with the precontoured distal radius plates.Developed through comprehensive morphologyanalysis, the plates rarely require bending to matchthe complex geometry of the distal radius. The platedesign expedites intraoperative restoration of thepatient’s anatomy, optimum plate placement andconstruct stabilization.

The anatomic contour provides optimizedintermediate and radial column support, whilefragments are structurally buttressed to the anatomy.Appropriately spaced distal screw holes deliveroptimal subchondral support and fragment reduction.

Plates, designed to minimize soft tissue disruption,naturally sit proximal to the watershed line.

Targeted locking screw holes provide enhancedfixation, precise to anatomic fragments of the radialstyloid and volar ulnar corner.

The preassembled, radiolucent guide block facilitateseasy plate insertion and preliminary plate fixationwith K-wires. The patent-pending design promotesproper plate and screw placement while reducing thenumber of steps, and potentially amount offluoroscopy, needed for implantation.

A K-wire hole targeted to the tip of the radial styloid provides access to reduce small and large fragments.

Plate window allows direct visualization, bone graft application and fragment manipulation through the plate.

Plates are manufactured from Grade 2 commercially pure titanium providing an elastic modulus closer to that of bone than titaniumalloy or stainless steel and reducing the propensity of stress shielding according to Wolff’s law.

All screw holes accept both locking and non-locking screws.

Plate trial templates simplify plate selection and act as bending template, for extreme anatomy.

Streamlined instrumentation provides ease of use with zero learning curve.

6

Lunate facet support screws

Three fixation points in theradial styloid

K-wire hole trajectory parallel toradial styloid targeted screws

Patent pending guide blockattachment mechanism

Oblong hole with measurementmarks to aid in plate positioning

Anatomic contour sits proximal to thewatershed line with rounded edges tolimit soft tissue irritation

K-wire holes providepreliminary fixation and adistal boundary of thenominal screw trajectory

Distal radioulnar jointsupported from targetedscrews

Converging K-wire holes inthe shaft provide rigidpreliminary plate fixation

Overall plate footprint is indicatedby trail footprint

Starting and ending points ofslot indicate location ofproximal and distal styloid-targeted screws

Slot angle indicates Radialtrajectory of styloid-targetedscrews

Marking calls out plate widthand corresponding partnumber

Circular features indicatelocking hole locations

Slot angle indicatesUlnar trajectory of ulnar-targeted screw

Right and Left plates arerepresented on oppositesides of the trial

K(123562 page 1/3

510(k) SUMMARY MAR 29 2013Flower Orthopedics Corporation's Flower Small and Medium Implants

Submftter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Flower Orthopedics Corporation7715 Crittenden Street, #413Philadelphia, PA 19118

Phone: +1 267 437 3063Facsimile: + 1 267 437 3072

Contact Person: Oliver B. Burckhardt

Date Prepared:. March 29, 2013

Name of Device and Name/Address of Sponsor

Flower Small and Medium Implants

Common or Usual Name

Bone plating system

Classification Name/ Product Code

Classification Name: 21 CFR 888.3030 - Single/multiple component metallic bone fixationappliance and accessories

Product Codes: HRS (Plate, Fixation, Bone), HWC (Screw, Fixation, Bone)

Predicate Devices

Synthes USA's 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System withExpanded Indications (K082807)

Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP)(K092609)

Strykers VariAx Distal Radius Locked Plating System Line Extension for Addition of AimingBlocks (K1 12455)

KLS-Martin Hand Plating System (K040598)Synthes 2.4mm VA-LCP Intercarpal Fusion System (K1 03243)

K123562 page 2/3

Intended Use I Indications for Use

The Flower Small and Medium Implants set is intended for use for internal fixation of fractures andreconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia,fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growthplates have fused. Examples of these internal fixations and reconstructions include compressionfractures, intra-articular and extraarticular fractures, displaced fractures, osteotomies, non-unionsand mal-unions.

This system can be used for palmar, ventral, dorsal or orthogonal application.

Technological Characteristics

The Flower Small and Medium Implants set consists of the follow ng components and accessories:pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesisplates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shapedplates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also providedwith general purpose instruments. All plates are made of pure titanium (ISO 5832-2).

The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates toassist with internal fixation of fractures and reconstruction of bones. The principles of operation ofthe device are similar to other bone plating systems. The plates are comprised of various shapes,alignments, thicknesses, widths, and lengths designed to contour to different bones and locations onthe body for internal fixation or reconstruction following fracture. Each of the plates contains severallocking holes that allow for the insertion of Flower Small and Medium Implants locking screws. Touse the Flower Small and Medium Implants set, the surgeon first selects an implant of theappropriate size and shape based on the intended site of use. The plate should be placed in anappropriate location on the given bone or anatomical location in need of repair.

Performance Data

In support of this 510(k) Premarket Notification, Flower Orthopedics has conducted the followingtesting. In all instances, the Flower Small and Medium Implants set functioned as intended.* Biocompatibility in accordance with ISO 10993-1, ISO 10993-5 was established, demonstrating

that the materials are non-cytotoxic and biocompatible.* Sterilization validation of implants and instruments demonstrated assurance level of 10-6 for

this method of sterilization using the specified gamma sterilization cycle.* Packaging validationand shelf life testing ensured that the packaging can maintain its physical

integrity and maintain a sterile barrier over the stated period.

Substantial Equivalence

The Flower Small and Medium Implants system is very similar to Synthes's 3.5 mm and 4.5 mmLocking Compression Plate (LCP) System with Expanded Indications (K082807), the Synthes 3.5mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP) (K092609), Stryker'sVariAx Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks(K1 12455), KLS-Martins Hand Plating System (K040598), and Synthes 2.4mm VA-LCP IntercarpalFusion System (K103243). The Flower Small and Medium Implants system has the same intended

k123562 Page 3/3

uses and similar indications, technological characteristics, and principles of operation as itspredicate devices. The overall surgical procedure for the Flower Small and Medium Implants setand the predicate devices are very similar and there are no new types of safety or effectivenessconcerns. The minor difference in the locking feature between the Flower system and the predicatesystems do not significantly alter the surgical technique. The minor technological differencesbetween the Flower Small and Medium Implants and its predicate devices, e.g., minor differences inthe range of available geometries and dimensions, raise no new types of safety or effectivenessquestions because these size differences are very minor and are largely encompassed within therange of similar parameters in the predicate devices. Engineering analysis has been performed todemonstrate that the Flower Small and Medium Implants system provides appropriate mechanicalstrength for its intended use. Thus, the Flower Small and Medium Implants system is substantiallyequivalent.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

a4 Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - W066-0609Silver Spring, MD 20993-002

Flower Orthopedics Corporation Letter dated: March 29, 2013% Hogan Lovells US LLPMs. Janice M. Hogan, Partner1835 Market Street, 29th FloorPhiladelphia, Pennsylvania 19103

Re: K123562Trade/Device Name: Flower Small and Medium ImplantsRegulation Number: 21 CFR 888.3030Regulation Name: Single/multiple component metallic bone fixation appliances and

accessoriesRegulatory Class: Class 11Product Code: HIRS, HWCDated: March 1, 2013Received: March 1, 2013

Dear Ms. Hogan:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRI- does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 -Ms. Janice M. Hogan

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to http://www.fda.izov/AboutFDA/CentersOffices/CDRHICDRHOffices/ucm II 5809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Pant807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttp://www.fda.gzov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.azov/MedicalDevices/ResourcesforYOLI/Industry/default.htm.

Sincerely yours,

Mark N. RN Ieerson -SMark N. MelkersonDirectorDivision of Orthopedic DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

Indications for Use Statement

51 0(k) N um ber (if known). Ki123562

Device Name: Flower Small and Medium Implants

Indications for Use:

The Flower Small and Medium Implants set is intended for use for internal fixation of fractures andreconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvs, distal tibia,fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growthplates have fused. Examples of these internal fixations and reconstructions include compressionfractures, i ntra-articular and extraarticular fractures; displaced fractures, osteotomies, non-unionsand mal-unions.


Prescription Use ___X-ADO Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) AN/R(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna R~sz t201 3.03.2'V542*749 -04'00'

Page _ of _

15

AUG 2 2 2013 K(131657 Page 1/2

5. 5 10(K) SUMMARY

[jSubmitter's Name: _ - Foer Orthopedics Corporation

Submitter's Address: F715 Crittenden Street, #413- - -~ - j Philadelphia, PA 19118

Submi tter's Telephone: J167-437-3063

_Submitter's Fax:_ - - - 267-437-3072 -

Authorized Contact Name: [ Janice M. Hogan

[Contact's Telephone: [267-675-4611- -----------

IContact's Email: janicetnogan~hoganlovells.com

Date Summary was [July 26, 2013Prepared: ----------------I-------

Trade or Proprietary Name: 'I [Fiower Small and Medium Implant Set

Common or Usual Nae [Bone plating system

[Classification: [Class [I per 21 CFR §888.3030 -

[roduct Codes: 9HRS, HWC

Classification Panel [[ Orthopedic and Rehabilitation Devices PanelJ

Predicate Devices: Flower Small and Medium Implant Set (K123562)ISynthes USA's 3.5 mmr and 4.5 mm Locking

Compression Plate (LCP) System withExpanded Indications (K082807)Stryker's VariAx Distal Radius Locked Plating SystemLine Extension for Addition of Aiming Blocks(KI 12455)KLS-Martin Hand Plating System (K040598)

CHANGE FROM PREDICATE:The purpose of this submission is to make modifications (line extensions) to the components ofthe Flower Small and Medium Implant Set cleared in K123562. The standard construct ismodified by adding sizes not included in the previous submission.

TECHNOLOGICAL CHARACTERISTICS:

The Flower Small and Medium Implants set consists of the following components andaccessories: pure titanium small straight plates, small and medium reconstmuction plates, mediumosteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates,angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. Thedevice is also provided with general purpose instruments.

Page I of 2 23

K131657 Page 2/2

INDICATIONS FOR USEThe Flower Small and Medium Implants set is intended for use for internal fixation of fractures

and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis,distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom thegrowth plates have fused. Examples of these internal fixations and reconstructions include

compression fractures, intra-articular and extra-articular fractures, displaced fractures,osteotomies, non-unions and mal-unions.


PERFORMANCE DATAIn support of this 5 1 0(k) Premarket Notification, Flower Orthopedics has conducted engineeringanalysis to demonstrate that the modifications to the Flower Small and Medium Implants set

provides adequate and substantially equivalent mechanical strength for its intended use.

CONCLUSIONThe Flower Small and Medium Implants system is very similar to previously cleared FlowerSmall and Medium Implant Set. The Flower Small and Medium Implants system has the sameintended uses and similar indications, technological characteristics, and principles of operation asthe previously cleared devices. The minor technological differences between the subject FlowerSmall and Medium Implants and its previously cleared devices raise no new types of safety or

effectiveness questions. The overall technology characteristics lead to the conclusion thatFlower Small and Medium Implant Set is substantially equivalent to the previously cleareddevices.

Page 2 of 2 24

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

42 Food and Drug AdministrationDocument Control Center - W066-0609Silver Spring, MID 20993-0002

Flower Orthopedics Corporation August 22, 2013%o Ms. Janice M. HoganPartnerHogan Lovells US LLP1835 Market Street, 29th FloorPhiladelphia, Pennsylvania 19103

Re: K131657Trade/Device Name: Flower Small and Medium Implant SetRegulation Number: 21 CFR 888.3030Regulation Name: Single/multiple component metallic bone fixation appliances and

accessoriesRegulatory Class: Class IIProduct Code: HRS, HWCDated: July 26, 2013Received: July 26, 2013

Dear Ms. Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Fo *od, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2!1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Act

or any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21

Page 2 - Ms. Janice M. Hogan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.gov/MedicalDevices/ResoucestbrYou/ndusrv/delatlt.ltin. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CER Part 803), please go tohttp://%"vw.fda.2ov/MedicalDevices/Safetv/Re~ortaProblein/dcfaulit.htin for the COR.H's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.pov/Medicaloevices/ResourcesforYou/inldustry/default.htni.

Sincerely yours,

Mark N. Melkerson -SMark N. MelkersonDirectorDivision of Orthopedic DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

K13 1657

4. INDICATIONS FOR USE STATEMENT

Device Name: Flower Small and Medium implant Set

The Flower Small and Medium Implants set is intended for use for internal fixation of fracturesand reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis,distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-2 1) in whom the

growth plates have fused. Examples of these internal fixations and reconstructions includecompression fractures, intra-articular and extra-articular fractures, displaced fractures,osteotomies, non-unions and mal-unions.


Prescription Use __X_ AND/OR Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D)) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERPAGE OF NEEDED)


Elizabeth L. Frank -SDivision of Orthopedic Devices

Flower Small and Medium Bone Plate Line Extension

Page 1 of 1

K 132248

510(k) SUMMARY

Flower Bone Screw Set

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Flower Orthopedics Corporation7715 Crittenden Street, #413Philadelphia, PA 19115

Phone: (267) 437 3063 OTFacsimile: (267) 437 3072

Contact Person: Oliver Burckhardt, Chief Executive Officer

Date Prepared: October 29, 2013

Name of Device and Name/Address of Sponsor

Flower Bone Screw Set

Common or Usual Name/Classification Name

Bone Fixation Screw

Product Codes: HWC; HTN (Orthopedic Review Panel)

Product Classifications: 21 C.F.R. 858.3040 - Smooth or Threaded Metallic Bone FixationFastner; 21 C.F.R. 858.3030 - Single/multiple component metallic bone fixation appliancesand accessories

Predicate Devices

Medical Facets Bone Fixation Screws and Pins (K1 12727)Howmedica Asnis Micro Cannulated Screw (K071092)Treu Bone Fixation Screws and Pins (K053912)Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943)Flower Small and Medium Implant Set (K1 23562)

Intended Use / Indications for Use

The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fusion ofjoints or bone reconstruction.

Device Description

The Flower Bone Screw Set consists of the following components and accessories: solid,cannulated, and headless compression screws, as well as washers, all made of a titaniumalloy compliant with ASTM F1 36. The device is provided with general purpose instruments.

Technological Characteristics

The Flower Bone Screw Set consists of the following components/configurations:

Page I of 2

K 132248

* Cannulated Bone Screws with a diameter range of 2.0-7.3mm and a length range of10.0-130.0mm;

* Solid Bone Screws with a diameter range of 2.0-4.5mm and a length range of 10.0-70.0mm; and

* Headless Compression Bone Screws with a 6.5mm diameter and a length range of45.0-130.0mm.

Performance Data

The Flower Bone Screw Set was tested (worse case) according to the following standards:

* ASTM Fl 36, Standard Specification for Wrought Titanium-6 Aiuminum-4 VanadiumELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401);

* ISO 7153-1, Surgical instruments - Metallic materials - Part 1: Stainless steel (ISO7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;

* ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process;

* ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity;

* ISO 11137-1, Sterilization of health care products - Radiation - Part 1:Requirements for development, validation and routine control of a sterilizationprocess for medical devices. (Sterility)

In addition, an engineering analysis has been performed to demonstrate that the FlowerOrthopedics cannulated, solid and headless compression bone screws provide appropriatemechanical strength for the claimed intended use.

In all instances, the Flower Bone Screw Set functioned as intended and test results, as wellas an engineering analysis, demonstrate substantial equivalence with the cited predicatedevices.

Substantial Equivalence

The Flower Bone Screw Set is substantially equivalent to the identified predicate devices.The subject devices have the same intended uses /indications, technological characteristics,and principles of operation as its predicate devices. An engineering analysis was performedto demonstrate that the Flower Orthopedics cannulated, solid and headless compressionbone screws provide appropriate mechanical strength for the claimed intended use. Thus,the subject bone screws are substantially equivalent.

Page 2 of 2

DEPARTMENT OF HEALTH& HUMAN SERVICES Public Health Serice

Food and Drug Administrationzc 10903 New Hamnpshire Avenue

Document Control Center - W066-G609

Silver Spring, MD 20993-0002

October 30, 2013

Flower Orthopedics Corporation% Ms. Janice M. HoganHogan Lovells US LLP1835 Market Street, 291h FloorPhiladelphia, Pennsylvania 19103

Re: K132248Trade/Device Name: Flower Bone Screw SetRegulation Number: 21 CFR 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastenerRegulatory Class: Class 11Product Code: HWC, HTNDated: September 18, 2013Received: September I8, 2013

Dear Ms. Hogan:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set


forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of SmallI Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.2ov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CER Part 803), please go tohttp://www.fda.Rov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH 's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 63 8-2041 or (301) 796-7100 or at its Internet addresshtti)://www.fda.pov[MedicalDevicesfResourcesforYou/Industry/default.htm.

Sincerely yours,

Enrirr e p Kiaeit hfor

Mark N. MelkersonDirectorDivision of Orthopedic DevicesQffice of Device EvaluationC enter for Devices and

Radiological Health

Enclosure


510(k) Number (if known): K132248

Device Name:


The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints

or bone reconstruction.

Prescription Use X AN/ROver-The-Counter Use ____

(Part 21 CFR 801 Subpart 0) AN/R(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)


Elizabeth 7l 39Frank -SPage 1 of 1

Division of Orthopedic Devices

41

(;/-D_E_P_:A_R_T_M_E_N_T_o_F_H_E_:A_L_T_H_&_u_u_M_:A_N_sE_R_v_1_c_E_s __________ :~-ub-li~-:-:-:-g-s:-~-:-.m-"stra-tt-.o-n ----

10903 New Hampshire Avenue

Flower Orthopedics Corporation % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: Kl33102 Trade/Device Name: Flower Ankle Plating Set Regulation Number: 21 CFR 888.3030

Document Control Center - W066-G609 Silver Spring, MD 20993-0002

November 18, 2013

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: HRS, HWC Dated: September 30, 2013 Received: September 30, 2013

Dear Ms. Hogan:

We have reviewed your Section 51 O(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA' s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21


CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803 ); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21CFR1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 ), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address htto://www.fda.gov/MedicalDevices/ResourcesforY ou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 .97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to htto://www .fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH' s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforY ou/Industry/default.htm.

Enclosure

Sincerely yours,

Mark ~t~rson -5

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and

Radiological Health


510(k) Number (if known): Kl 33102 -----------~

Device Name: Flower Ankle Plating Set


The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically,

• Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,

• Distal Tibia A-Plates are intended to buttress partial articular fractu~es and bone fragments of the distal tibia, and

• Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use __ _ (21 CFR 801 Subpart C)


------------------------------------·-·-----


Elizabeth L. Frank -5 Division of Orthopedic Devices

Page 1 of 1

41

~ \£ .. VICts.(I

('.-'- DEPARTMENT OF HEAL TH & HUMAN SERVICES

~#.~~ Public Health Service

:tb,Ja~

Flower Orthopedics Corporation Mr. Gary Barnett RA/QA Manager I 00 Witmer Road, Suite 280 Horsham, Pennsylvania I 9044

Re: Kl33930 Trade/Device Name: Flower Rearfoot Plating Set Regulation Number: 21 CFR 888.3030

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609

·Silver Spring, MD 20993-0002

March 27, 2014

Regulation Name: Single/multiple component metallic bone fixation appliance and accessories

Regulatory Class: Class II Product Code: HRS, HWC Dated: December 31, 2013 Received: January 03, 2014

Dear Mr. Barnett:

We have reviewed your Section 51 O(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act {Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing ·practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA' s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Mr. Gary Barnett

forth in the quality systems (QS) regulation (2 1 CFR Part 820); and if applicable, the electronic product rad iation contro l provisions (Sections 53 1-542 of the Act); 2 1 CFR I 000-1 050.

If you desire specific advice for your dev ice on our labeling regulation (2 1 CFR Part 80 I), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-204 1 or (30 I) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part 807.97). For questions regarding the reporting of adverse events under the MOR regulation (2 1 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default. htm for the CDR.H 's Office of Survei llance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general informat ion on yo ur responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Ass istance at its toll-free number (800) 63 8-204 1 or (30 I) 796-71 00 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/defau lt.htm.

Enclosure

Sincerely yours,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and

Radiological Health


510{k) Number {if known):._--=K=l:.=3-=3 ...... 9 __ 30 _______ _

Device Name: Flower Rearfoot Plating Set


The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use __ _ (21 CFR 801 Subpart C)


Concurrence of CDRH, Office of Device Evaluation {ODE)

Elizabet~a=rank-5 Division of Orthopedic Devices

Page_of_

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