Corentec Co., Ltd.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Corentec Co., Ltd.” (first 2010, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 72 days, against 90 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 111 |
| 2013 | 2 | 29 |
| 2014 | 0 | — |
| 2015 | 2 | 126 |
| 2016 | 3 | 277 |
| 2017 | 3 | 64 |
| 2018 | 0 | — |
| 2019 | 2 | 159 |
| 2020 | 3 | 32 |
| 2021 | 2 | 96 |
| 2022 | 3 | 90 |
| 2023 | 2 | 109 |
| 2024 | 2 | 25 |
| 2025 | 1 | 23 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Corentec Co., Ltd. took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 | 12 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 12 | 12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (33)
Most recent Corentec Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250889 | EXULT Knee Replacement System | JWH | 2025-04-17 | 23 |
| K242401 | EXULT Knee Replacement System | JWH | 2024-09-12 | 30 |
| K242046 | EXULT Knee Replacement System | JWH | 2024-08-01 | 20 |
| K223828 | BENCOX Delta Option Heads | LZO | 2023-03-16 | 85 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | LPH | 2023-02-27 | 133 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | JWH | 2022-08-26 | 28 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | LPH | 2022-05-24 | 449 |
| K220468 | BENCOX Mirabo Cup System | LPH | 2022-05-18 | 90 |
| K212034 | LOSPA TKR System | JWH | 2021-12-09 | 163 |
| K211866 | Bencox THR System | LPH | 2021-07-14 | 28 |
23 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2024-03-29.
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 Corentec Co., Ltd.?
FDA lists 33 510(k) clearances under the applicant name “Corentec Co., Ltd.” (first 2010, latest 2025), 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 Corentec Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corentec Co., Ltd. is 90 days. Since 2017: 72 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Corentec Co., Ltd.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 12); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 12); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 2).
Next steps
- See all 33 Corentec Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Corentec Co., Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.