Depuy Ireland UC: FDA clearances and approvals
Depuy Ireland UC has 50 FDA 510(k) clearances (first 2018, latest 2026), across 16 product codes in 2 review panels. Median 510(k) review time: 101 days. Since 2017 its median was 101 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Depuy Ireland UC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 307 |
| 2019 | 0 | — |
| 2020 | 6 | 118 |
| 2021 | 7 | 92 |
| 2022 | 9 | 155 |
| 2023 | 9 | 77 |
| 2024 | 10 | 92 |
| 2025 | 3 | 30 |
| 2026 | 5 | 112 |
Review time against the same product codes
Since 2017, Depuy Ireland UC's cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 8 | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 | 6 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 6 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 6 | 6 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 | 6 |
| OLO | Orthopedic Stereotaxic Instrument | 4 | 4 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
Plus 6 more product codes.
Review panels
- Orthopedic (49)
- Radiology (1)
Most recent Depuy Ireland UC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | JWH | 2026-06-25 | 55 |
| K260480 | VELYS Robotic-Assisted Solution | OLO | 2026-06-25 | 132 |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | KWL | 2026-05-15 | 87 |
| K253624 | INHANCE Reverse Shoulder System | PHX | 2026-03-11 | 113 |
| K253551 | VELYS Hip Navigation | QIH | 2026-03-06 | 112 |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | JWH | 2025-11-19 | 54 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | LZO | 2025-05-23 | 28 |
| K243977 | EMPHASYS Acetabular System | LPH | 2025-01-22 | 30 |
| K243248 | INHANCE INTACT | PKC | 2024-12-23 | 73 |
| K242871 | ATTUNE Revision Hinge Knee | KRO | 2024-11-21 | 59 |
40 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-12-19.
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.
Frequently asked questions
How many FDA 510(k) clearances does Depuy Ireland UC have?
Depuy Ireland UC has 50 FDA 510(k) clearances (first 2018, latest 2026), across 16 product codes in 2 review panels.
How long does FDA take to clear Depuy Ireland UC's 510(k)s?
The median time from FDA receipt to decision across Depuy Ireland UC's cleared 510(k)s is 101 days. Since 2017: 101 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Depuy Ireland UC make?
Its most frequent FDA product codes are PHX (Shoulder Prosthesis, Reverse Configuration, 8); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 6); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 6).
Has Depuy Ireland UC had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Depuy Ireland UC; the most recent began 2022-12-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 50 Depuy Ireland UC clearances with predicates and recalls
- Run predicate analysis for product code PHX, Depuy Ireland UC'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.