Corin USA: FDA clearances and approvals
Corin USA has 57 FDA 510(k) clearances (first 1996, latest 2021), plus 1 PMA decision, across 22 product codes in 4 review panels. Median 510(k) review time: 110 days. Since 2017 its median was 137 days, against 102 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 126 |
| 2013 | 6 | 110 |
| 2014 | 0 | — |
| 2015 | 1 | 190 |
| 2016 | 2 | 229 |
| 2017 | 0 | — |
| 2018 | 2 | 81 |
| 2019 | 2 | 196 |
| 2020 | 4 | 224 |
| 2021 | 1 | 110 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Corin USA's cleared 510(k)s took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 20 | 20 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 2 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 2 |
Plus 12 more product codes.
Review panels
Most recent Corin USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203751 | OMNIVision system | OLO | 2021-04-12 | 110 |
| K202805 | Optimized Positioning System (OPS) Insight | LLZ | 2020-11-20 | 58 |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | LZO | 2020-08-04 | 228 |
| K193042 | Optimized Positioning System (OPS) ReView | LLZ | 2020-06-26 | 239 |
| K192656 | Optimized Positioning System (OPS) Insight | LLZ | 2020-05-01 | 219 |
| K190143 | LARS AC Band Device | HTN | 2019-11-04 | 279 |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | LZO | 2019-07-22 | 112 |
| K183038 | Corin Optimized Positioning System (OPS) Plan | LLZ | 2018-11-26 | 25 |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | LZO | 2018-09-07 | 137 |
| K152893 | Corin Optimized Positioning System (OPS) | LZO | 2016-06-03 | 247 |
47 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050016 | PMA | CORMET HIP RESURFACING SYSTEM | 2007-07-03 |
Recalls
openFDA lists no recalls under a recalling firm named Corin USA.
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 USA have?
Corin USA has 57 FDA 510(k) clearances (first 1996, latest 2021), plus 1 PMA decision, across 22 product codes in 4 review panels.
How long does FDA take to clear Corin USA's 510(k)s?
The median time from FDA receipt to decision across Corin USA's cleared 510(k)s is 110 days. Since 2017: 137 days, versus 102 days for all cleared 510(k)s in the same product codes.
What devices does Corin USA make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 20); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 4); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 4).
Has Corin USA had device recalls?
openFDA lists no recalls under a recalling firm name matching Corin USA. Related entities may recall under other names.
Next steps
- See all 57 Corin USA clearances with predicates and recalls
- Run predicate analysis for product code LZO, Corin USA'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.