Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Orthopaedics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
480 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI | Johnson & Johnson Orthopaedics, Inc. | 1994-12-06 | 622 | 0 |
| K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMP | Johnson & Johnson Orthopaedics, Inc. | 1994-10-06 | 328 | 0 |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Johnson & Johnson Orthopaedics, Inc. | 1994-09-29 | 259 | 0 |
| K933275 | P.F.C. CERAMIC HIP HEAD | Johnson & Johnson Orthopaedics, Inc. | 1994-09-28 | 449 | 0 |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | Johnson & Johnson Orthopaedics, Inc. | 1994-09-20 | 480 | 0 |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1994-06-09 | 430 | 0 |
| K933867 | UNIVERSAL INSET PATELLA | Johnson & Johnson Orthopaedics, Inc. | 1994-06-06 | 301 | 0 |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | Johnson & Johnson Orthopaedics, Inc. | 1994-06-03 | 212 | 0 |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | Johnson & Johnson Orthopaedics, Inc. | 1994-02-09 | 337 | 0 |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | Johnson & Johnson Orthopaedics, Inc. | 1994-01-25 | 330 | 0 |
| K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT | Johnson & Johnson Orthopaedics, Inc. | 1994-01-25 | 515 | 0 |
| K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR | Johnson & Johnson Orthopaedics, Inc. | 1993-10-04 | 235 | 0 |
| K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | Johnson & Johnson Orthopaedics, Inc. | 1993-02-12 | 165 | 0 |
| K924984 | SPECIALIST(R) WALKER | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 | 123 | 0 |
| K924115 | ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS | Johnson & Johnson Orthopaedics, Inc. | 1992-11-24 | 102 | 0 |
| K913629 | JOHNSON AND JOHNSON POWER SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1991-11-13 | 90 | 0 |
| K914439 | P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL | Johnson & Johnson Orthopaedics, Inc. | 1991-10-23 | 19 | 0 |
| K910968 | P.F.C. UNICONDYLAR KNEE SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1991-08-26 | 173 | 0 |
| K904737 | GROSS HIP FEMORAL COMPONENT | Johnson & Johnson Orthopaedics, Inc. | 1991-07-26 | 281 | 0 |
| K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL | Johnson & Johnson Orthopaedics, Inc. | 1991-05-23 | 104 | 0 |
| K904300 | INSET PATELLAR COMPONENT | Johnson & Johnson Orthopaedics, Inc. | 1990-10-17 | 28 | 0 |
| K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT | Johnson & Johnson Orthopaedics, Inc. | 1990-06-26 | 46 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda