Corin U.S.A. Limited: FDA clearances and approvals
Corin U.S.A. Limited has 21 FDA 510(k) clearances (first 2016, latest 2025), across 8 product codes in 2 review panels. Median 510(k) review time: 132 days. Since 2017 its median was 179 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 3 | 88 |
| 2017 | 3 | 242 |
| 2018 | 4 | 200 |
| 2019 | 3 | 167 |
| 2020 | 1 | 191 |
| 2021 | 0 | — |
| 2022 | 1 | 279 |
| 2023 | 1 | 92 |
| 2024 | 3 | 115 |
| 2025 | 2 | 234 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Corin U.S.A. Limited's cleared 510(k)s took a median 179 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 6 | 6 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 | 5 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (19)
- Radiology (2)
Most recent Corin U.S.A. Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242744 | Trinity EVO Acetabular Shell | LPH | 2025-06-05 | 267 |
| K241808 | ApolloHipX (THR.SS.0001) | LLZ | 2025-01-07 | 200 |
| K241472 | Icona Hip Stem | MEH | 2024-10-03 | 132 |
| K241570 | Unity Total Knee System | JWH | 2024-09-23 | 115 |
| K240875 | Unity Knee PS-C Tibial Insert | JWH | 2024-06-26 | 89 |
| K231172 | ApolloKnee | OLO | 2023-07-26 | 92 |
| K212069 | Corin MetaFix Hip Stem | LZO | 2022-04-07 | 279 |
| K191831 | MobiliT Cup | LZO | 2020-01-16 | 191 |
| K191374 | Revival Modular Hip Stem | LZO | 2019-07-22 | 60 |
| K183114 | Corin BiPolar-i | KWY | 2019-06-05 | 208 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Corin U.S.A. Limited.
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 Corin U.S.A. Limited have?
Corin U.S.A. Limited has 21 FDA 510(k) clearances (first 2016, latest 2025), across 8 product codes in 2 review panels.
How long does FDA take to clear Corin U.S.A. Limited's 510(k)s?
The median time from FDA receipt to decision across Corin U.S.A. Limited's cleared 510(k)s is 132 days. Since 2017: 179 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Corin U.S.A. Limited make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 6); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 5); MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, 3).
Has Corin U.S.A. Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Corin U.S.A. Limited. Related entities may recall under other names.
Next steps
- See all 21 Corin U.S.A. Limited clearances with predicates and recalls
- Run predicate analysis for product code LZO, Corin U.S.A. Limited'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.