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Wright Medical Group, Inc.
A Global Orthopaedic Medical Device Company
We are a global orthopaedic medical device company specializing in the design, manufacture, and marketing of reconstructive joint devices and biologics. Wright's product offerings include large joint implants for the hip and knee; extremity implants for the hand, elbow, shoulder, foot and ankle; and both synthetic and tissue-based bone graft substitute materials.
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Wright Medical Group, Inc.
Two Fundamentally Solid Platforms
EXTREMITIES and BIOLOGICS
40%
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ORTHO-RECON
60%
Foot & Ankle Product Portfolio - Most comprehensive & innovative
INBONE® Total Ankle
CHARLOTTE™ CLAW® 3.5mm Implant
BIOFOAM® Wedge
LIS FRANC® Plate
ORTHOSPHERE® Implant
SWANSON® Hammer Toe Implant
CHARLOTTE™ Snap-Off Screw
GRAFTJACKET® Ulcer Repair Matrix
LPT® Toe Implant
MTP® Plate
DARCO® BOW Plate
BIO-ARCH® Implant
ENDO-FUSE® Rods and Beams
CHARLOTTE™ Compression
CHARLOTTE™ CLAW® 2.7mm Implant
CHARLOTTE™ Jones Fracture Screw
DART-FIRE® Screws
CHARLOTTE™ 3.0 MUC Screw
DARCO® Screws
SWANSON Great Toe DARCO®
RPS Plate
DARCO® MPJ Plate
DARCO® LPS Plate
DARCO® PIA Plate
DARCO® DPS Plate
ORTHOLOC® Plate
CHARLOTTE 7.0 MUC Screw
AM® Surgical Endoscopic Blade
SIDEKICK® Stealth Fixation
CORETRAK® Tube Fixator
ORTHOLOC® Plate
SIDEKICK® Fixation
VALOR® NAIL Fixation
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GRAFTJACKET® Graft
EVOLVE® Implant
MICRONAIL® Implant
SWANSON® Finger Implant
RAYHACK® Radial Malunion
RAYHACK® Ulnar Shortening
EVOLVE® Plate
Upper Extremity Product Portfolio - Legacy Leadership In Niche Segments
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Ortho Recon – Innovative Knee Portfolio
ADVANCE Medial Pivot 10+ Years of clinical success
Medial-Pivot Kinematics
MIS Instrumentation
Cementless Fixation
Patient-Specific Instruments
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Ortho Recon – Innovative Hip Portfolio
Innovative & Comprehensive Acetabular Systems
CONSERVE® Total with BFH® Technology Hip System
Confidence with Stability.
CONSERVE® PLUS Total Hip
Resurfacing
Modular Hip Systems
Resurfacing & BFH Modularity Bearing Options
DYNASTY® Acetabular with BIOFOAM®
CANCELLOUS TITANIUM™
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Quality System
• Global Quality System Certifications Ø ISO 13485:2003 Ø ISO 9001:2008
• AATB Accredited Tissue Bank
• FDA Establishment Registration #1043534
Quality System Overview
We will meet or exceed the expectations of our customers by complying with requirements,
by maintaining the effectiveness of the quality management system, by training employees, and
by designing and building quality into our products.
QualityPolicy
• Fostering Device Innovation – DeNovo reforms to the regulatory pathway for
lower-risk novel devices with no 510k option, but which do not warrant the PMA requirement for higher-risk devices
– 510(k) program reform: • CDRH plan to incorporate new scientific information into
regulatory decision making • Draft guidance on Device Modifications: Deciding When to
Submit a 510(k) for a Change to an Existing Device • Refuse to Accept Guidance • E-Copy Draft FDA Guidance
• Implementation of UDI in labeling
FDA Initiatives …
• Approval Challenges – 510(k)
Recent Trends
Standard of care in question Slower reviews- Spending total review time allowed before generating additional questions Increase in 510(k) conversion (Specialà Traditional) based on supportive data (eg. Test data, adverse event reports) Additional scrutiny of pre-clinical data Device intended for use in Class II and Class III applications must be split into 2 separate 510k filings. Ex. Hip 510ks now require duplicate filings (MoM vs MoP, CoP)
Reviewers recent enforcement related to E-Copy and Refuse to Accept Draft Guidance Historical performance (Corrective Fixes)
Corrective Fixes
Device launched
Fixes made and intent to launch
Adverse events w/ root cause
Original device recalled, obsoleted, or continued to be sold
• Not eligible as Special 510k since data review req’d
• How to address corrective fix in the filing? • Typically want sponsor to be able to replicate the
failure mode observed clinically • Demonstrate that comparatively the modified device
should not fail in similar capacity • Demonstrate that subject device is equivalent to ‘non-
defective’ device
Pre- Clinical Data Bench testing not demonstrating equiv. to predicate. Subject not performing as well.
• New patient population within scope of intended use/indications for use (possibly a specific indication for use)
• New technological characteristics that may have
clinical impact (e.g. device affects surrounding bones)
• Device performs below level of predicate device on the bench and clinical ramifications are not known/cannot be predicted in an animal model
• Approval Challenges – 510(k) – Letter to the File
Device modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device • 1997 Guidance vague and
requires interpretation • 2011 draft guidance was closed
for comments, but later dropped by FDA
• Fewer changes qualify - Ex. Sizes outside of cleared range require 510k regardless of worst case determination
• FDA scrutiny of LTF process expected during Quality audits
Recent Trends
• Approval Challenges – 510(k) – LTF – Instruments
Enforcement of inclusion in PMA /510k filing “Unique instruments” take on classification of device:
Recent Trends
• Approval Challenges – 510(k) – LTF – Instruments – Customs
• Strict FDA interpretation of current guidance • “One-of-a-kind” device limited to physician or dentist
• If another company makes device, it is “generally available” / not custom
• Device that could be used for >1 patient is not custom
• Modification to an existing device (shorter, fatter, left-handed, etc) is “customized,” not custom, and requires a pre-market submission
• Burden of proof lies with manufacturer • Increase of Compassionate Use requests to due to strict interpretation of policy. • New guidance delayed by FDA
Recent Trends
• Approval Challenges – 510(k) – LTF – Instruments – Customs – Labeling
Lack of FDA guidance for new communication methods (eg. Social Media guidance delayed) General vs Specific claims Text Requirement in Device Labeling
• All symbols on outer package label must be accompanied by text on the outer package label.
Fair & balanced promo Final guidance on the implementation of UDI
Recent Trends
International Trends
• Country of Origin identification • Limited Global government resources (reviewers) • Re-registration of devices licensed before early 2000’s
—causing approval delays (Latin America) • Increased requests for additional data to support new
product registrations and license renewals • Strict adherence to test standards (mechanical,
biocompatibility of final implants) • EU: New regulations to impact CE Marking • Canada: Uncertainty from Health Canada regarding
licensing of instruments (regulations vague on “grouping”)
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Wright Initiatives • Review of company-wide policies and procedures to ensure continued compliance to evolving regulations (domestic and global)
• Delays in review have required the adjust of internal timelines for new product launches, as well as global renewals
• Review and streamline of product portfolio. Product redeployment initiated for R.O.W. markets.
• Communication with FDA to enlist least burdensome approach for UDI implementation
• Active involvement with industry groups (eg . AdvaMed, OSMA)
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