Johnson & Johnson Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Johnson & Johnson Orthopaedics, Inc.” (first 1990, latest 1994), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 247 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 | 7 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | 1 | 1 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
- Orthopedic (21)
- General Hospital (1)
Most recent Johnson & Johnson Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI | JWH | 1994-12-06 | 622 |
| K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | LZO | 1994-10-06 | 328 |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | KWL | 1994-09-29 | 259 |
| K933275 | P.F.C. CERAMIC HIP HEAD | LZO | 1994-09-28 | 449 |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | LZN | 1994-09-20 | 480 |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | KWY | 1994-06-09 | 430 |
| K933867 | UNIVERSAL INSET PATELLA | JWH | 1994-06-06 | 301 |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | JWH | 1994-06-03 | 212 |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | LZO | 1994-02-09 | 337 |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | JWH | 1994-01-25 | 330 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Johnson & Johnson Orthopaedics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Johnson & Johnson Professionals, Inc. (206 510(k)s)
- Johnson & Johnson Medical, Inc. (56 510(k)s)
- Johnson & Johnson Clinical Diagnostics, Inc. (33 510(k)s)
- Johnson & Johnson Vision Care, Inc. (12 510(k)s)
- Johnson & Johnson (10 510(k)s)
- Johnson & Johnson International (10 510(k)s)
- Johnson & Johnson Consumer Products, Inc. (8 510(k)s)
- Johnson & Johnson Medical, Div. of Ethicon, Inc. (5 510(k)s)
- Johnson & Johnson Surgical Vision, Inc. (4 510(k)s)
- Johnson & Johnson Patient Care, Inc. (4 510(k)s)
- Johnson and Johnson (2 510(k)s)
- Johnson & Johnson Company (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Johnson & Johnson Orthopaedics, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Johnson & Johnson Orthopaedics, Inc.” (first 1990, latest 1994), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Johnson & Johnson Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Johnson & Johnson Orthopaedics, Inc. is 247 days.
Which FDA product codes appear under Johnson & Johnson Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 22 Johnson & Johnson Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Johnson & Johnson Orthopaedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.