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Product Information Cementless Threaded Cup System *smith&nephew BICON-PLUS

*smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

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Page 1: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

Product InformationCementless Threaded Cup System

*smith&nephewBICON-PLUS ™

Page 2: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

02 Product Information

With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular

system has been clinically proven in the management of primary and revision

cases with a stable anchorage without additional screw fixation.1, 2, 4, 9, 10

Threaded cups offer a high primary stability.12

The first generation of BICON-PLUS was introduced in 1992. In 2002 the second

generation, with a closed shell rim, was launched. Today, more than 450,000 units

have been sold all over the world.

We remain just as convinced today as we were 25 years ago, that the conical

principle provides conditions allowing primary stability and secondary

osteointegration in cementless cup anchoring.1,2,4,7,8

Clinically proven for over 25 Years

Page 3: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

03

BICON-PLUS™

Double cone principle

The anatomical approximation to the acetabulum requires less bone resection, compared to a conical

shaped cup.4, 5

Biconical shell design

The biconical design provides an approximation of the implant to the spherical form of the bony

acetabulum.

Thread and tooth profile

The sharp-cutting thread blades of the BICON-PLUS cup enable penetration of the thread teeth into

the subchondral sclerotic zone.7 The thread and tooth profile is anatomically adapted for all cup sizes.

Articulation bearings

The BICON-PLUS system has a wide range of combination options, making it suitable for many

different surgical indications. Either hard-soft or hard-hard-bearing, whereby the comprehensive range

includes cross-linked polyethylene (XLPE), conventional polyethylene (PE) and BIOLOX® delta inserts.

Most XLPE and PE inserts are also available in an antiluxation version. Different ball head diameters

are available, ranging up to 36mm, depending on the cup size.

Page 4: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

04 Product Information

Features

The double cone

• The anatomical approximation to the acetabulum

requires less bone resection compared to a conical

shaped cup.4, 5

• Broad seating in the acetabulum, especially at the front

end of the cup

• Possibility to fully screw into the previously reamed bony

bed, thanks to the tooth and thread form

The tooth form

• Tooth size, tooth thickness and tooth height matched to

cup size

• Thread and tooth size increase with increasing cup size:

- smaller cup – smaller thread and tooth form

- larger cup – larger thread and tooth form

The surface roughness

• The average roughness of the titanium shell is 5 µm2

• The dual-taper design, together with the macrostructure

of the thread teeth, ensures reliable primary stability

and, in combination with the surface microstructure,

promotes long-term osteointegration.1, 2, 4, 7, 8

The closed rim

• Direct PE-bone contact can be avoided

Page 5: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

05

BICON-PLUS™

The sector closure

• Open sectors allow full view during the implantation

procedure

• Spongiosaplasty can be performed through these

openings, if necessary

• After screwing in the cup shell, the sectors are closed

to avoid any polyethylene-bone contact

The articulation bearings

• XLPE (highly crosslinked PE) standard version for ball

heads 22, 28, 32 and 36 mm, and antilux version for

ball heads 22, 28 and 32 mm

• PE standard and antiluxation version for ball heads

22, 28 and 32 mm

• BIOLOX® delta Ceramic/PE-insert standard version for

ball heads 32 and 36 mm

Axial form closure due to snap lock

TITANIUM CUP/CERAMIC PE INSERT

TITANIUM CUP/PE INSERT

Anchoring of the PE insert in the titanium cup by means of four conus connections

Page 6: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

06 Product Information

BIOLOX® delta (AI208, ZrO2)

BIOLOX® delta Standard

XLPE/PE Standard

XLPE/PE Antilux

BICON-PLUS™ System

BICON-PLUS Standard

Shells Inserts Ball heads

BIOLOX® OPTION

Metal Standard

OXINIUM

Materials

BICON-PLUS cup shell

High-grade-forged pure titanium according to ISO standard 5832-2

PE inserts

UHMW polyethylene according to ISO standard 5834-2

XLPE inserts

Highly cross-linked polyethylene made of form-pressed GUR-1050

UHMW-PE according to ISO standard 5834-2

Ceramic/PE inserts BIOLOX® delta

High quality aluminum (Al203)/zirconium oxide (ZrO2)

Composite ceramic BIOLOX® delta according to

ISO standard 6474-2.2

Shells

Size/Ø mm Standard

01/37* x

0/40* x

1/43 x

2/46 x

3/49 x

4/52 x

5/56 x

6/59 x

7/63 x

8/68* x

9/72* x

Inserts

Material 22 28 32 36

PE insert Standard 01 – 0 1 – 6 2 – 7

PE insert Antilux 01 – 0 1 – 6 2 – 7

XLPE insert Standard 01 – 0 1 – 6 2 – 7 3 – 9

XLPE insert Antilux 0 1 – 6 2 – 7

BIOLOX® delta/PE insert Standard

3–4 5 – 9

Ball head Ø/size mm

*Special sizes

Page 7: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

07

BICON-PLUS™

Clinical ResultsZweymüller et al.1 report an implant survival rate of 99.3% after 10 years. The endpoint was revision

for any reason. They also observed that even in problematic cases there was an increase in

bone substance around the cranial margin of the cup and the socket floor, indicating secondary

osteointegration. On examination the standard ultra-high-molecular-weight (UHMW) polyethylene

cup inserts demonstrated low abrasion rates (0.13 mm/year).1 Stable anchorage of the polyethylene

(UHMW) insert in the cup is essential to ensure reduced polyethylene abrasion2. The authors of the

study concluded: “These intermediate results compare favorably with survivorship and periacetabular

bone reaction data observed with the best cementless acetabular implant designs“. Milosev et al 11

report an implant survival rate of 99.5% after 10 years, with aseptic revision as the endpoint in the

metal-polyethylene articulation bearings.

Conclusions: To date results published by experts on the BICON-PLUS screw cup design have been

consistently positive. Numerouse studies have proven excellent survival rates of over 99%.1,2,4,9,11

Summary of publication ‘Good Stability and Minimal Osteolysis with a Biconical Threaded Cup

at 10 Years.’ by Karl A. Zweymüller et al 1:

Between January 1993 and June 1994, 376 BICON-PLUS cups were implanted in combination with

a ceramic-on-PE articulation. 232 hips were reviewed after 10.0 to 13.1 (mean 10.3) years. The mean

Harris hip score was 93.1 at 10 years and more. The 10-year Kaplan-Meier survivor curve with revision

for any reason as an event of interest was 99.3% (95% CI: 96.9 – 99.8%). There were two implant

revisions. One revision was attributable to an infection and one was for cup fracture. No liner was

exchanged because of wear problems or instability. Mean liner head penetration was 1.33 mm with a

standard deviation of 0.66 mm, equaling a mean linear wear rate of 0.13 mm per year. Gaps between

the cup floor and the bone tended to be spontaneously obliterated by newly formed bone.

Page 8: *smith&nephew BICON-PLUS...With its Bi-conical shape Smith & Nephew’s BICON-PLUS threaded acetabular system has been clinically proven in the management of primary and revision cases

0123

Manufacturer

Smith & Nephew Orthopaedics AG

Oberneuhofstrasse 10d

6340 Baar

Switzerland

OXINIUM™ is a registered trademark from Smith & Nephew Inc., CE0086. BIOLOX® delta, BIOLOX® forte and BIOLOX® OPTION are registered trademarks from CeramTec GmbH, Germany, CE0123.

™Trademark of Smith & Nephew 01857-en V3 (2191) 09/18

1 Zweymüller KA, Steindl M, Schwarzinger U. Good stability and minimal osteolysis with a biconical threaded cup at 10 years. Clin Orthop Relat Res. 2007 Oct;463:128–137 2 Zweymüller KA, Redesigned Threaded, Double-Cone Titanium Cups Yield Excellent Mid-Term Results. Orthopaedics Crossfire. 2006;29(9):809-811. 3 Zweymüller K, Schwarzinger U, Steindl M. Radiolucent lines and osteolysis along tapered straight cementless titanium hip stems: a comparison of 6-year and 10-year follow-up results in 95 patients; Acta Orthop. 2006;77(6):871–876 4 Korovessis P, Repantis T, Zafiropoulos A. High medium-term survivorship and durability of Zweymuller-Plus total hip arthroplasty. Archives of Orthopaedic and Trauma Surgery. 2011;131(5):603-611; 5 Veldstra R, van Dongen A, Kraaneveld EC. Comparing alumina-reduced and conventional surface grit-blasted acetabular cups in primary THA: early results from a randomised clinical trial. Hip International. 2012;22(3):296-301 6 Studers P, Belajevs D, Jurkevics V, Likums P. Ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population. International Orthopaedics (SICOT), DOI 10.1007/s00264-015-2846-z 2016;40(3):465-471 7 Effenberger H, Imhof M, Witzel U. Criteria for Success with Threaded Cups. Acta Chirurgiae Orthopaedicae et Traumatologiae Cechosl. 2003;70: 285-291 8 Effenberger H, Imhof M, Witzel U, Kaelin P, Rieger W. Modifications of Shape, Material and Modularity of Threaded Cups. Biomed Technik. 2002;47(6):169-291 9 Li H, Zhang S, Wang XM, Lin JH, Kou BL. Medium-term results of ceramic-on-polyethylene Zweymuller-Plus total hip arthroplasty. Hong Kong Medical Journal. 2017;23(4):333-339 10 Schmolders J, Amvrazis G, Pennekamp PH, et al. Thirteen year follow-up of a cementless femoral stem and a threaded acetabular cup in patients younger than fifty years of age. International Orthopaedics. 2017;41(1):39-45 11 Milosev I, Kovac S, Trebse R, Levasic V, Pisot V. Comparison of Ten-Year Survivorship of Hip Prostheses with Use of Conventional Polyethylene, Metal-on-Metal, or Ceramic-on-Ceramic Bearings. JBJS Am. 2012;94:1756-63. 12 Kody MH, Kabo JM, Markolf KL, Dorey FJ, Amstutz HC. Strength of initial mechanical fixation of screw ring acetabular components. Clin. Orthopa Relat Res. 1990; (257): 146-53