Corin Orthopedic Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Corin Orthopedic Products” (first 1993, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 376 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Corin Orthopedic Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931753 | CORIN THOMPSON PROSTHESIS, MODIFICATION | KWL | 1994-10-07 | 547 |
| K931752 | CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION | KWL | 1994-10-07 | 547 |
| K934166 | NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION | JWH | 1994-09-07 | 376 |
| K925866 | CENATOR TOTAL HIP SYSTEM | JDI | 1993-09-23 | 308 |
| K925897 | CORIN BIPOLAR PROSTHESIS | KWY | 1993-08-09 | 263 |
Recalls
openFDA lists no recalls under a recalling firm named Corin Orthopedic Products.
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.
- Corin USA (57 510(k)s)
- Corin U.S.A. Limited (21 510(k)s)
- Corin, Ltd. (4 510(k)s)
- Corin Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corin Orthopedic Products?
FDA lists 5 510(k) clearances under the applicant name “Corin Orthopedic Products” (first 1993, latest 1994), across 4 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 Corin Orthopedic Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corin Orthopedic Products is 376 days.
Which FDA product codes appear under Corin Orthopedic Products?
The most frequent FDA product codes under this applicant name are KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 2); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 1).
Next steps
- See all 5 Corin Orthopedic Products clearances with predicates and recalls
- Run predicate analysis for product code KWL, Corin Orthopedic Products'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.