Company ยท US
Johnson & Johnson Orthopaedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1994. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | 1 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LZN | Cement Obturator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 1994 | K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI Johnson & Johnson Orthopaedics, Inc. | JWH |
| Oct 6, 1994 | K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Orthopaedics, Inc. | LZO |
| Sep 29, 1994 | K940190 | ULTIMA UNIPOLAR MODULAR HEAD Johnson & Johnson Orthopaedics, Inc. | KWL |
| Sep 28, 1994 | K933275 | P.F.C. CERAMIC HIP HEAD Johnson & Johnson Orthopaedics, Inc. | LZO |
| Sep 20, 1994 | K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR Johnson & Johnson Orthopaedics, Inc. | LZN |
| Jun 9, 1994 | K931655 | P.F.C. BIPOLAR HIP SYSTEM Johnson & Johnson Orthopaedics, Inc. | KWY |
| Jun 6, 1994 | K933867 | UNIVERSAL INSET PATELLA Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jun 3, 1994 | K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA Johnson & Johnson Orthopaedics, Inc. | JWH |
| Feb 9, 1994 | K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET Johnson & Johnson Orthopaedics, Inc. | LZO |
| Jan 25, 1994 | K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jan 25, 1994 | K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT Johnson & Johnson Orthopaedics, Inc. | JWH |
| Oct 4, 1993 | K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR Johnson & Johnson Orthopaedics, Inc. | LZO |
| Feb 12, 1993 | K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM Johnson & Johnson Orthopaedics, Inc. | KWL |
| Feb 1, 1993 | K924984 | SPECIALIST(R) WALKER Johnson & Johnson Orthopaedics, Inc. | FYH |
| Nov 24, 1992 | K924115 | ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS Johnson & Johnson Orthopaedics, Inc. | JDI |
| Nov 13, 1991 | K913629 | JOHNSON AND JOHNSON POWER SYSTEM Johnson & Johnson Orthopaedics, Inc. | HSZ |
| Oct 23, 1991 | K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL Johnson & Johnson Orthopaedics, Inc. | HSX |
| Aug 26, 1991 | K910968 | P.F.C. UNICONDYLAR KNEE SYSTEM Johnson & Johnson Orthopaedics, Inc. | HRY |
| Jul 26, 1991 | K904737 | GROSS HIP FEMORAL COMPONENT Johnson & Johnson Orthopaedics, Inc. | JDI |
| May 23, 1991 | K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL Johnson & Johnson Orthopaedics, Inc. | JWH |
| Oct 17, 1990 | K904300 | INSET PATELLAR COMPONENT Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jun 26, 1990 | K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT Johnson & Johnson Orthopaedics, Inc. | JDI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||