Depuy, Inc.: FDA filings under this applicant name
FDA lists 303 510(k) clearances under the applicant name “Depuy, Inc.” (first 1976, latest 2005), plus 4 PMA decisions, across 94 product codes in 9 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 45 | 45 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 31 | 31 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 24 | 24 |
| HWC | Screw, Fixation, Bone | 14 | 14 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 12 | 12 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 11 | 11 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 7 | 7 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 6 | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 | 6 |
Plus 84 more product codes.
Review panels
- Orthopedic (261)
- General and Plastic Surgery (13)
- General Hospital (11)
- Dental (5)
- Ophthalmic (3)
- Cardiovascular (2)
- Gastroenterology and Urology (1)
- Neurology (1)
- Physical Medicine (1)
Most recent Depuy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | KWZ | 2005-03-14 | 129 |
| K042664 | LPS UPPER EXTREMITY | JDC | 2004-12-08 | 71 |
| K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY | JWH | 2004-07-22 | 87 |
| K033959 | LPS | JWH | 2004-07-01 | 192 |
| K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 | LPH | 2004-05-28 | 87 |
| K021478 | DELTA SHOULDER | PHX | 2003-11-18 | 559 |
| K033329 | DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS | HSB | 2003-11-14 | 29 |
| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | JWH | 2003-09-26 | 74 |
| K020541 | AGILITY ANKLE REVISION PROSTHESIS | HSN | 2002-05-20 | 90 |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | KRO | 2001-09-07 | 88 |
293 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960001 | PMA | DEPUY 1 BONE CEMENT | 1997-02-11 |
| P910016 | PMA | NEW JERSEY LCS(R) TOTAL KNEE SYSTEM | 1992-10-30 |
| P830055 | PMA | LCS(R) TOTAL KNEE SYSTEM | 1985-04-12 |
| N18466 | PMA | CMW BONE CEMENT | 1984-02-22 |
Recalls
openFDA lists no recalls under a recalling firm named Depuy, 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.
- DePuy Orthopaedics, Inc. (210 510(k)s)
- Depuy Spine, Inc. (71 510(k)s)
- Depuy Mitek, A Johnson & Johnson Company (58 510(k)s)
- Depuy Ireland UC (50 510(k)s)
- DePuy Synthes (20 510(k)s)
- Depuy Mitek (15 510(k)s)
- Depuy Ace Medical Co. (10 510(k)s)
- Depuy Motech Acromed (4 510(k)s)
- Depuy Spine, A Johnson & Johnson Company (4 510(k)s)
- Depuy Mitek, A Johnson and Johnson Company (3 510(k)s)
- Depuy Mitek, Inc., A Johnson and Johnson Company (3 510(k)s)
- Depuy Synthes Spine (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Depuy, Inc.?
FDA lists 303 510(k) clearances under the applicant name “Depuy, Inc.” (first 1976, latest 2005), plus 4 PMA decisions, across 94 product codes in 9 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 Depuy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy, Inc. is 80 days.
Which FDA product codes appear under Depuy, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 45); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 31); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 24).
Next steps
- See all 303 Depuy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Depuy, 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.