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) |
|---|---|---|---|
| May 14, 2012 | Zimmer Inc. 90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23 mm Height; Sterile, Rx ,Zimmer, I Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Sterile, Rx ,Zimmer, Inc. Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Sterile, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Artic Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Artic Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | K003910 K892800 +2 |
| Mar 2, 2012 | Biomet, Inc. REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE
Signature Personalized Patient Care System is Terminated |
JWH | K102795 |
| Feb 21, 2012 | Aesculap Implant Systems Columbus Tibia Plateau (component of the Columbus REVISION Knee System)
Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by o Terminated |
JWH | K083772 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | K002335 |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | K002335 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemoroti Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemoroti Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Thin Patella size 28mm, three pegs - 184782,
Sterile, Biomet Orthopedics, Warsaw, IN 46582
For use with Vanguard, Maxim, Ascent & AGC Knee Systems
Knee joint patellofemorotibial, ceme Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedics, Warsaw, IN 46582
For use with Vanguard, Maxim, Ascent & AGC Knee Systems
Knee joint patellofemorotibial, Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582
For use with Vanguard, Maxim, Ascent & AGC Knee Systems
Knee joint patellofemorotibial, Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, Warsaw, IN 46582
For use with Vanguard, Maxim, Ascent & AGC Knee Systems
Knee joint patellofemorotibial, cemente Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Thin Patella size 25mm, one peg - 184720
Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems
Knee joint patellofemorotibial, cemented Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with
Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582
Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For Terminated |
JWH | K040770 |
| Jan 11, 2012 | Biomet, Inc. Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems.
Knee joint patellofemorotibia Terminated |
JWH | K040770 |
| Dec 2, 2011 | Encore Medical, Lp Foundation Tibial Broach P/N 801-01-013
Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for accepta Terminated |
JWH | K970031 |
| Aug 30, 2011 | DePuy Orthopaedics, Inc. PFC Sigma Round Dome Patella 38 MM 3 Peg
Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cemen Terminated |
JWH | K884796 |
| Aug 4, 2011 | Biomet, Inc. Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY.
Biomet, Inc.
A knee joint replacement prosthesis non-coated femoral indicated for cemented application onl Terminated |
JWH | K023546 |
| Apr 28, 2011 | Biomet, Inc. Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prosth Terminated |
JWH | None listed |
| Apr 28, 2011 | Biomet, Inc. Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prosthes Terminated |
JWH | K915132 |
| Mar 16, 2011 | Stryker Howmedica Osteonics Corp. SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
The Tibial trial are utilized during surgery to assess the overall component f Terminated |
JWH | None listed |
| Feb 11, 2011 | Stryker Howmedica Osteonics Corp. Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary o Terminated |
JWH | K031729 |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Jan 7, 2011 | Ortho Development Corporation CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02. Terminated |
JWH | K060370 K960279 |
| Dec 2, 2010 | Zimmer Inc. Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01. Terminated |
JWH | K060370 K960279 |
| Oct 21, 2010 | Zimmer Inc. NexGen Complete Knee Solution Stemmed Tibial
Component Precoat Size 3, REF 00-5980-037-01, Sterile, Zimmer, Warsaw, IN.
Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium Terminated |
JWH | K933785 |
| Oct 21, 2010 | Zimmer Inc. NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN.
Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromiu Terminated |
JWH | K933785 |
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