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) |
|---|---|---|---|
| Oct 6, 2010 | Stryker Howmedica Osteonics Corp. Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600.
Made in Ireland;
Howmedica Osteonics;
325 Corporate Drive,
Mahwah, NJ 07430
Intended for primary or secondar Terminated |
JWH | K920034 |
| Sep 20, 2010 | Zimmer Inc. TRABECULAR METAL FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32.
The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary Terminated |
JWH | K040630 |
| Sep 20, 2010 | Zimmer Inc. TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31.
The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary Terminated |
JWH | K040630 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw, IN.
This device is indicated for patient Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4+ (Plus), sterile, REF 00-5950-037-12, Zimmer Inc. Warsaw, IN.
This device is indicated for Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN.
This device is indicated for patient Terminated |
JWH | K043101 |
| Sep 13, 2010 | Zimmer Inc. NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN.
This device is indicated for patients Terminated |
JWH | K043101 |
| Aug 31, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Knee System Primary Tibial Baseplate;
Sterile, Made in Ireland.
Howmedica Osteonics
325 Corporate Drive
Mahwah, NJ 07430
The Triathlon system is comprised of a femoral component, tib Terminated |
JWH | K031729 K040267 |
| Aug 22, 2010 | Encore Medical, Lp 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. Terminated |
JWH | K020114 |
| Aug 10, 2010 | Biomet, Inc. Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component. Terminated |
JWH | K023546 |
| May 21, 2010 | Wright Medical Technology Inc ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
Indicated for use in Terminated |
JWH | K972770 |
| May 21, 2010 | Wright Medical Technology Inc ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
Indicated for use in k Terminated |
JWH | K972770 |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, B-P Type II Talar Ankle Component:
Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101,
Size 2 B-P Ty Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. TMJ Components:
Right Ramus Component - DelCristo Catalog: 09-11-0215,
TMJ - Shah Catalog: 09-42-0217, 09-11-0217.
Left Fossa Component - DelCristo Catalog 09-42-0216,
Left Ramus Component - DelCrist Terminated |
JWH | None listed |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, F-P Type III Ankle Bearing Component:
2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532,
2x7mm F-P Type III Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Ankle, Titanium Alloy, Sterilized.
BP Ankle System, Talar Ankle Component:
Size 2 Talar Component Catalog: 05-01-0002,
Size 3 Talar Component Catalog: 05-01-0003,
Size 4 Talar Com Terminated |
JWH | K842234 K904870 +1 |
| May 20, 2010 | Endotec, Inc. Endotec Prothesis Hip, Titanium Alloy, Sterilized.
Acetabular Bearing, BP Hip System Component:
32x54 Acetabular Bearing, Catalog: 01-02-3254,
32x56 Acetabular Bearing, Catalog: 01-02-3256,
Femora Terminated |
JWH | K963101 |
| May 20, 2010 | Endotec, Inc. Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized
Modular Femoral Stem BP Shoulder Component:
12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374. Terminated |
JWH | K904880 |
| May 20, 2010 | Endotec, Inc. Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP))
The B-P Knee Replacement System is composed of sev Terminated |
JWH | K012702 |
| Apr 26, 2010 | Encore Medical, Lp 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445.
Intended to aid the surgion in relieving the patient of knee pain and restoring k Terminated |
JWH | K020114 |
| Apr 7, 2010 | Encore Medical, Lp Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 Terminated |
JWH | K932246 |
| Apr 5, 2010 | Ortho Development Corporation 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from sever Terminated |
JWH | K031201 |
| Apr 5, 2010 | Ortho Development Corporation 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from Terminated |
JWH | K031201 |
| Mar 31, 2010 | Wright Medical Technology Inc ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002.
The device is intended for us Terminated |
JWH | K973524 |
| Mar 16, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R.
Mahwah, NJ Terminated |
JWH | K030978 |
| Mar 10, 2010 | Zimmer Inc. Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02.
The Terminated |
JWH | K072160 |
| Mar 2, 2010 | Zimmer Inc. NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN. Terminated |
JWH | K060370 |
| Mar 2, 2010 | Stryker Howmedica Osteonics Corp. Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ.
Intended to be used with cemented or cementless components in primary or Terminated |
JWH | K051977 |
| Mar 2, 2010 | Stryker Howmedica Osteonics Corp. Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ.
Intended to be used with femoral components in primary or revision total knee arthroplast Terminated |
JWH | K031729 |
| Feb 24, 2010 | Encore Medical, Lp Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left Terminated |
JWH | K932425 |
| Feb 19, 2010 | Stryker Howmedica Osteonics Corp. Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics.
Intended for cemented application to replace the articulating Terminated |
JWH | K962152 |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | K070095 |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | K070095 |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component;
For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended fo Terminated |
JWH | K070095 |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are intended for Terminated |
JWH | K070095 |
| Feb 1, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Stabilizer Femoral Component; Size # 2
for Use with TS Components; Sterile, Made in the USA
Stryker Orthopaedics, Mahwah, NJ 07430.
The Triathlon Total Knee System components are int Terminated |
JWH | K070095 |
| Jan 13, 2010 | Encore Medical, Lp Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate in Terminated |
JWH | K932425 |
| Dec 14, 2009 | Zimmer Inc. Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-57 Terminated |
JWH | K060370 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, #9 left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arth Terminated |
JWH | K030978 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, # 7 left/right;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total kn Terminated |
JWH | K030978 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, # 5 Left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07340.
The Scorpio Femoral Components are a knee component that is utilized in total knee art Terminated |
JWH | K030978 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral. # 4 left/right;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total kn Terminated |
JWH | K030978 |
| Dec 1, 2009 | Stryker Howmedica Osteonics Corp. Scorpio NRG Posterior Stabilized Femoral, #3 Left;
Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The Scorpio Femoral Components are a knee component that is utilized in total knee arth Terminated |
JWH | K030978 |
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