Depuy(Ireland): FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Depuy(Ireland)” (first 2010, latest 2022), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 143 days, against 106 days for all cleared 510(k)s in the same product codes. 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 | 1 | 107 |
| 2015 | 1 | 312 |
| 2016 | 2 | 98 |
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 4 | 146 |
| 2020 | 1 | 143 |
| 2021 | 0 | — |
| 2022 | 1 | 148 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Depuy(Ireland) took a median 143 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Depuy(Ireland) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212683 | GLOBAL ICON Stemless Shoulder System | PKC | 2022-01-19 | 148 |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | 2020-02-24 | 143 |
| K190344 | DePuy Corail AMT Hip Prosthesis | LZO | 2019-11-01 | 260 |
| K191779 | Attune Revision LPS Inserts | KRO | 2019-10-08 | 98 |
| K192448 | Delta Xtend Revers Shoulder System | PHX | 2019-10-04 | 28 |
| K183077 | Delta Xtend Reverse Shoulder System | PHX | 2019-05-17 | 193 |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | JWH | 2017-06-15 | 90 |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | 2016-07-19 | 109 |
| K160700 | ATTUNE Revision Knee System | JWH | 2016-06-10 | 88 |
| K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | MBH | 2015-02-13 | 312 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Depuy(Ireland).
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Depuy(Ireland)?
FDA lists 13 510(k) clearances under the applicant name “Depuy(Ireland)” (first 2010, latest 2022), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Depuy(Ireland)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy(Ireland) is 120 days. Since 2017: 143 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Depuy(Ireland)?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 4); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 2).
Next steps
- See all 13 Depuy(Ireland) clearances with predicates and recalls
- Run predicate analysis for product code PHX, Depuy(Ireland)'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.