DePuy Orthopaedics, Inc.: FDA clearances and approvals
DePuy Orthopaedics, Inc. has 210 FDA 510(k) clearances (first 1998, latest 2026), plus 3 PMA decisions, across 46 product codes in 4 review panels. Median 510(k) review time: 72 days. Since 2017 its median was 57 days, against 108 days for all cleared 510(k)s in the same product codes. openFDA lists 740 product recalls by a recalling firm named DePuy Orthopaedics, Inc. It is the industry lead sponsor of 32 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 178 |
| 2013 | 2 | 249 |
| 2014 | 1 | 171 |
| 2015 | 1 | 177 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 448 |
| 2019 | 3 | 42 |
| 2020 | 5 | 54 |
| 2021 | 1 | 29 |
| 2022 | 1 | 28 |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 163 |
Review time against the same product codes
Since 2017, DePuy Orthopaedics, Inc.'s cleared 510(k)s took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 33 | 33 |
| HRS | Plate, Fixation, Bone | 18 | 18 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 17 | 17 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 16 | 16 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 12 | 12 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 12 | 12 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 | 9 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 9 | 9 |
| LOD | Bone Cement | 9 | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 7 | 7 |
Plus 36 more product codes.
Review panels
- Orthopedic (205)
- Neurology (4)
- General and Plastic Surgery (3)
- Radiology (1)
Most recent DePuy Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262130 | ATTUNE Revision Knee System | JWH | 2026-09-04 | 72 |
| K252887 | DePuy ATTUNE Knee System | OIY | 2026-05-22 | 254 |
| K231503 | CUPTIMIZE Advanced | LLZ | 2023-08-22 | 90 |
| K213839 | DePuy Corail AMT Hip Prosthesis | LZO | 2022-01-06 | 28 |
| K210167 | DELTA XTEND Reverse Shoulder System | PHX | 2021-02-19 | 29 |
| K203167 | DePuy Corail AMT Hip Prosthesis | LZO | 2020-11-19 | 27 |
| K202472 | ACTIS Duofix Hip Prosthesis | LPH | 2020-10-21 | 54 |
| K201347 | DePuy ATTUNE Total Knee System | OIY | 2020-06-18 | 28 |
| K193540 | TRUMATCH Personalized Solutions | JWH | 2020-06-16 | 179 |
| K193398 | Summit DuoFix HA Coating | MEH | 2020-02-04 | 60 |
200 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090002 | PMA | PINNACLE COMPLETE ACETABULAR HIP SYSTEM | 2011-06-13 |
| P070026 | PMA | CERAMAX CERAMIC HIP SYSTEM | 2010-12-23 |
| P040023 | PMA | DURALOC OPTION CERAMIC HIP SYSTEM | 2005-05-03 |
Recalls
740 product recalls in 87 recall events; 19 initiated in the last five years. Most recent: 2024-03-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
DePuy Orthopaedics, Inc. is the industry lead sponsor of 32 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06631638: EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) (Recruiting, started 2025-10-24)
- NCT06323980: INHANCE Stemless Reverse Shoulder IDE (Recruiting, started 2025-03-04)
- NCT04730271: Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty (Completed, started 2021-02-23)
- NCT03542045: China ATTUNE® Study (Completed, started 2018-04-12)
- NCT03153449: ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population (Active not recruiting, started 2017-09-19)
Frequently asked questions
How many FDA 510(k) clearances does DePuy Orthopaedics, Inc. have?
DePuy Orthopaedics, Inc. has 210 FDA 510(k) clearances (first 1998, latest 2026), plus 3 PMA decisions, across 46 product codes in 4 review panels.
How long does FDA take to clear DePuy Orthopaedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across DePuy Orthopaedics, Inc.'s cleared 510(k)s is 72 days. Since 2017: 57 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does DePuy Orthopaedics, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 33); HRS (Plate, Fixation, Bone, 18); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 17).
Has DePuy Orthopaedics, Inc. had device recalls?
openFDA lists 740 product recalls in 87 recall events by a recalling firm whose name matches DePuy Orthopaedics, Inc; the most recent began 2024-03-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 210 DePuy Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, DePuy Orthopaedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.