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 1, 2013 | Smith & Nephew Inc GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.
Product Usage: orthopaedic Terminated |
JWH | K951987 |
| Nov 1, 2013 | Smith & Nephew Inc GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168.
Product Usage: orthopaedic Terminated |
JWH | K951987 |
| Oct 25, 2013 | Zimmer, Inc. Sidus" Head (Not distributed in the United States) Terminated |
JWH | None listed |
| Oct 25, 2013 | Zimmer, Inc. Natural-Knee II Femoral Component Terminated |
JWH | K936159 |
| Oct 25, 2013 | Zimmer, Inc. Natural-Knee Flex Femoral Component.
Provides increased flexion capability. Terminated |
JWH | K936159 |
| Oct 25, 2013 | Zimmer, Inc. NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R
CR-FLE Terminated |
JWH | K060370 |
| Oct 25, 2013 | Zimmer, Inc. NexGen Femoral Component
(CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R Terminated |
JWH | K060370 |
| Sep 3, 2013 | Stelkast Co SC2316, Distal Femoral Augment with Screw
Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous Terminated |
JWH | K021908 |
| Aug 22, 2013 | Smith & Nephew Inc GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490,
Product Usage:
Orthopedic Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile;
00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile;
00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, R Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile;
00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile;
00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, R Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile;
00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile;
00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile;
00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile;
00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, R Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile;
00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile;
00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile;
00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile;
00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile;
Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile;
00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile;
00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile;
00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile;
00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile;
00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile;
Used in total knee arthroplasty and indicated for patients with Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile;
00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile;
Used in total knee arthroplasty and indicated for patients with severe p Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile;
00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile;
00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile;
00 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile;
00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile;
00597604114 Articular Surface AC ART SURF 56/STRIP Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile;
00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile;
00597204112 Articular Surface CR ART SURF 56/STRIPE G Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile;
90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile;
90597004112 Articular Surface CR ART SURF AE56/STR Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile;
00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile;
00597004112 Articular Surface CR ART SURF 56/STRI Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile;
90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile;
Used in total knee arthroplasty and indicated fo Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile;
00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile;
00595204114 Articular Surface XLPE CR ART SURF 5 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile;
00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile;
00597603110 Articular Surface AC ART SURF 34/STRIP Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile;
00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile;
00597203112 Articular Surface CR ART SURF 34/STRIPE Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile;
90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile;
90597003112 Articular Surface CR ART SURF 34/STR YEL 1 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile;
00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile;
00597003112 Articular Surface CR ART SURF 34/STRIPE Y Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile;
90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile;
Used in total knee arthroplasty and indicated fo Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile;
00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile;
00595203114 Articular Surface XLPE CR ART SURF 3,4/S Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile;
00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile;
00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile;
Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile;
00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile;
00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile;
90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile;
90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile;
00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile;
00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, S Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile;
90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile;
Used in total knee arthroplasty and indicated for pa Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile;
00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile;
00595202014 Articular Surface XLPE CR ART SURF 1,2/PU Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile;
00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile;
00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile;
0059 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile;
00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile;
00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile;
0058780 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile;
65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile;
65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile;
65597201434 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile;
00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile;
00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile;
00597201 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile;
00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile;
00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile;
00597201404 Femur CR POR FM C Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile;
00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile;
00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile;
00597001 Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile;
00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile;
00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile;
00597001404 Femur CR PR Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 65595201201 Femur CR-FLEX POR HATCP FEM B-L
Rx, Sterile;
65595201202 Femur CR-FLEX POR HATCP FEM B-R
Rx, Sterile;
Used in total knee arthroplasty an Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595201201 Femur CR-FLEX POR FEM B-L
Rx, Sterile;
00595201202 Femur CR-FLEX POR FEM B-R
Rx, Sterile;
Used in total knee arthroplasty and indicated for patients with severe pain. Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595001201 Femur CR-FLEX PCT FEM B-L
Rx, Sterile;
00595001202 Femur CR-FLEX PCT FEM B-R
Rx, Sterile;
Used in total knee arthroplasty and indicated for patients with se Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00595601201 Femur CR-FLEX OPT FEM B-L
Rx Sterile;
00595601202 Femur CR-FLEX OPT FEM B-R
Rx Sterile;
Used in total knee arthroplasty and indicated for patients with severe pain. Terminated |
JWH | None listed |
| Aug 22, 2013 | Zimmer, Inc. 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile;
00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile;
Used in total knee arthroplasty and indicated for patients with severe pain. Terminated |
JWH | None listed |
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