Panels › Orthopedic › Product code JWH · Class 2
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation 888.3560
14510(k)s in 12 months (921 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
Top companies in JWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 51 | 304 |
| DePuy Orthopaedics, Inc. | 16 | 102 |
| Smith & Nephew, Inc. | 49 | 60 |
| Exactech, Inc. | 32 | 64 |
| Howmedica Osteonics | 32 | 61 |
| Zimmer Biomet, Inc. | 0 | 85 |
| Biomet, Inc. | 40 | 44 |
| Stryker Howmedica Osteonics | 0 | 64 |
| Conformis, Inc. | 40 | 19 |
| Encore Medical L.P. | 15 | 44 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-02 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-020 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left,19 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-0 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424- Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-0 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2 sterile, Zimmer, Warsaw, IN; REF 00-5424-011-1 Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-011-11.
Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-011-09.
T Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 19 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-19. Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-16. Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-13. Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-11. Terminated |
JWH | K070214 |
| Nov 13, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-09
Terminated |
JWH | K070214 |
| Sep 11, 2009 | Medacta Usa Inc Evolis-Femoral Sizer Posterior Reference
The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The f Terminated |
JWH | K081023 |
| Sep 9, 2009 | Ortho Development Corporation Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020.
The Balanced Knee System is indicated in the salva Terminated |
JWH | K994370 |
| Aug 23, 2009 | Smith & Nephew Inc LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116.
The device is used for Orthopedic Knee Implants. Terminated |
JWH | K043440 |
| Aug 23, 2009 | Smith & Nephew Inc LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116.
The device is used for Orthopedic Knee Implants. Terminated |
JWH | K043440 |
| Aug 21, 2009 | Depuy Orthopaedics, Inc. DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005.
The device is used for total Terminated |
JWH | K943462 |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 8MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the k Terminated |
JWH | K070095 |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the kn Terminated |
JWH | K070095 |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the kn Terminated |
JWH | K070095 |
| Jul 23, 2009 | Stryker Howmedica Osteonics Corp. Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the k Terminated |
JWH | K070095 |
| Jul 15, 2009 | Stryker Howmedica Osteonics Corp. Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile;
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
For total knee arthroplasty procedures involving Triathlon Total Sta Terminated |
JWH | None listed |
| Jul 15, 2009 | Stryker Howmedica Osteonics Corp. Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile,
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
For total knee arthroplasty procedures involving Triathlon Total Terminated |
JWH | None listed |
| Jul 7, 2009 | Stryker Howmedica Osteonics Corp. Duracon Total Knee, A-P Lipped Tibial Insert; 11MM
Sterile; Howmedica Osteonics Corp.
Stryker, Ireland. Product No. 6642-1-611.
The device is used to replace bearing surface if the proximal tibia in Terminated |
JWH | K915512 |
| Jun 30, 2009 | Zimmer Inc. Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-200.
The Natural-Knee II System Cem Terminated |
JWH | K023528 |
| Jun 30, 2009 | Zimmer Inc. Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200.
The Natural-Knee II System Ceme Terminated |
JWH | K023528 |
| Jun 30, 2009 | Zimmer Inc. Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002.
The Natural-Knee II System Cemented Mod Terminated |
JWH | K023528 |
| Jun 30, 2009 | Zimmer Inc. Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-002.
The Natural-Knee II System Cemented Modu Terminated |
JWH | K023528 |
| Jun 26, 2009 | Zimmer Inc. Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01.
Knee implant used to Terminated |
JWH | K070214 |
| Mar 3, 2009 | Stryker Howmedica Osteonics Corp. Triathlon X3 Posterior Stabilized Tibial Insert
Use with Triathlon PS Femoral Components.
Sze 7, THKNS 13 m and SZE 8, THKNS 13mm;
Catalog number 5532-G-713, Catalog number 5532-G-813
Stryker Orthopae Terminated |
JWH | K051146 |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon-Press-Fit Stem
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee art Terminated |
JWH | K070095 |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon Cemented Stem - Knee
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total kn Terminated |
JWH | K053514 |
| Jan 9, 2009 | Zimmer Inc. Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230.
The modular cemented tibial baseplate is indicated Terminated |
JWH | K023528 |
| Nov 25, 2008 | Stelkast Co Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm.
The Proven Knee System is a single use device intended for cemented reconstruction of the f Terminated |
JWH | K980276 |
| Nov 21, 2008 | Biomet, Inc. Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN.
A knee prosthesis intended for single use implantation to rep Terminated |
JWH | K041046 |
| Sep 29, 2008 | Encore Medical, Lp FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE S Terminated |
JWH | K923277 K941306 +1 |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Osteonics Scorpio Total Knee;
Posteriorly Stabilized Femoral Component; #13
with posts, low friction Ion treatment.
Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Terminated |
JWH | K962152 |
| Aug 20, 2008 | Encore Medical, Lp 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758.
Used in surgery to determine the correct size of 3DKnee component to implant Terminated |
JWH | K020114 |
| Jul 25, 2008 | Biomet, Inc. Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464. Terminated |
JWH | K023546 |
| Jul 25, 2008 | Biomet, Inc. Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448. Terminated |
JWH | K023546 |
| Jul 16, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedic Terminated |
JWH | K962152 |
| Jul 16, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Terminated |
JWH | K974556 |
| Jan 31, 2008 | Biomet, Inc. Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581 Terminated |
JWH | K915132 |
| Jan 31, 2008 | Biomet, Inc. Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581 Terminated |
JWH | K915132 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
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