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) |
|---|---|---|---|
| Aug 22, 2013 | Zimmer, Inc. 65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile;
65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile;
65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile;
65597201202 Femur CR Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile;
00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile;
00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile;
00597201232 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile;
65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile;
65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile;
65597201232 F Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile;
00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile;
00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile;
00597201202 Femur Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile;
00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile;
00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile;
00 Terminated |
JWH | None listed |
| Jul 31, 2013 | DePuy Orthopaedics, Inc. LPS Lower Extremity Dovetail Intercalary component.
Intended for use in replacement of the mid-shaft portion of the femur. Terminated |
JWH | K041085 |
| May 24, 2013 | Orthopedic Alliance LLC UKNEE Patella,small 2401-1010
UKNEE Patella,medium 2401-1020
UKNEE Patella,large 2401-1030
UKNEE Patella,X-large 2401-1040
UKNEE Onset Patella, 3 pegs, x-small 2403-1010
UKNEE Onset Patella, 3 pegs, Terminated |
JWH | K103733 |
| May 24, 2013 | Orthopedic Alliance LLC Tibial baseplate,cemented,#1 2203-3010
Tibial baseplate,cemented,#2 2203-3020
Tibial baseplate,cemented,#3 2203-3030
Tibial baseplate,cemented,#4 2203-3040
Tibial baseplate, cemented, #5 2203-3050
Tib Terminated |
JWH | K103733 |
| May 24, 2013 | Orthopedic Alliance LLC Femoral component, CR, cemented, #1, left 2103-1310
Femoral component, CR, cemented, #2, left 2103-1320
Femoral component, CR, cemented, #3, left 2103-1330
Femoral component, CR, cemented, #4, left 21 Terminated |
JWH | K120507 |
| May 23, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package
Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA
Stryker France, ZAC Satolas Green Pusignan Terminated |
JWH | K070095 |
| Apr 5, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA.
Str Terminated |
JWH | None listed |
| Mar 15, 2013 | Exactech, Inc. Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. Terminated |
JWH | K071738 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: R Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile
This drill guide is used with the Persona Knee System for patients with severe knee pai Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile
This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE H, LEFT
TIBIA SIZE H RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE G, LEFT
TIBIA SIZE G RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE F, LEFT
TIBIA SIZE F RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE E, LEFT
TIBIA SIZE E RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid art Terminated |
JWH | K113369 |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
SIZE C, LEFT; SIZE C RIGHT
This device is indicated for patients with severe knee pain and disabi Terminated |
JWH | K113369 |
| Nov 26, 2012 | Zimmer, Inc. NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component
The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee Terminated |
JWH | K872379 |
| Sep 28, 2012 | Zimmer, Inc. Cemented Tibial Drill
Product Usage:
The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engrave Terminated |
JWH | K113369 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm
Ref: KC-54060.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm
Ref: KC-54050.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm
Ref: KC-54040.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm
Ref: KC-54030.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm
Ref: KC-54020.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm
Ref: KC-54010.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 4, 2012 | Exactech, Inc. OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011.
There are three product sizes being recal Terminated |
JWH | K093360 |
| Aug 21, 2012 | Exactech, Inc. OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508.
The Optetrak Comprehens Terminated |
JWH | K071738 |
| Aug 17, 2012 | Conformis Inc Conformis iTotal CR-Cruciate Retaining Knee Replacement System
Model Numbers:
M57250600010 iTotal CR, Left Knee
M57250600020 iTotal CR, Right Knee
Product Usage : Usage:
The iTotal CR Knee Replac Terminated |
JWH | K103117 |
| Jul 24, 2012 | Exactech, Inc. Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***".
The O Terminated |
JWH | K933610 |
| May 14, 2012 | Materialise USA LLC PATIENT SPECIFIC INSTRUMENTS
N-K FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer Terminated |
JWH | K111492 |
| May 14, 2012 | Materialise USA LLC PATIENT SPECIFIC INSTRUMENTS
LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID--0242-LF
Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer, W Terminated |
JWH | K111492 |
| May 14, 2012 | Zimmer Inc. 00-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. W Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5976-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 17 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
| May 14, 2012 | Zimmer Inc. 00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 14 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | K003910 K892800 +2 |
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