Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corentec Co., Ltd. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
277 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 | 23 | 0 |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-09-12 | 30 | 0 |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-08-01 | 20 | 0 |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | 2023-03-16 | 85 | 0 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023-02-27 | 133 | 0 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumen | Corentec Co., Ltd. | 2022-08-26 | 28 | 0 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022-05-24 | 449 | 0 |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022-05-18 | 90 | 0 |
| K212034 | LOSPA TKR System | Corentec Co., Ltd. | 2021-12-09 | 163 | 0 |
| K211866 | Bencox THR System | Corentec Co., Ltd. | 2021-07-14 | 28 | 0 |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral componen | Corentec Co., Ltd. | 2020-07-30 | 24 | 0 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020-05-07 | 79 | 0 |
| K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020-03-06 | 32 | 0 |
| K192507 | LOSPA II Knee System | Corentec Co., Ltd. | 2019-12-11 | 90 | 0 |
| K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019-04-01 | 228 | 0 |
| K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017-10-17 | 29 | 0 |
| K170243 | LOSPA IS TLIF & DLIF Cages | Corentec Co., Ltd. | 2017-03-31 | 64 | 0 |
| K161641 | LOSPA IS ACP System | Corentec Co., Ltd. | 2017-01-05 | 205 | 0 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016-12-05 | 126 | 1 |
| K160157 | LOSPA Modular Knee System | Corentec Co., Ltd. | 2016-12-01 | 314 | 2 |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Ste | Corentec Co., Ltd. | 2016-04-29 | 277 | 0 |
| K151408 | LOSPA IS Spinal System | Corentec Co., Ltd. | 2015-10-02 | 129 | 0 |
| K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015-05-04 | 122 | 0 |
| K132644 | LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD | Corentec Co., Ltd. | 2013-09-19 | 24 | 0 |
| K130673 | LOSPA TOTAL KNEE REPLACEMENT SYSTEM | Corentec Co., Ltd. | 2013-04-15 | 34 | 2 |
| K122099 | BENCOX II STEM, BENCOX METAL HEAD | Corentec Co., Ltd. | 2012-10-05 | 81 | 0 |
| K121665 | BENCOX FORET & BENCOX DELTA | Corentec Co., Ltd. | 2012-09-25 | 111 | 0 |
| K120924 | BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED T | Corentec Co., Ltd. | 2012-09-10 | 167 | 0 |
| K121037 | LOSPA TIBIAL BASE PLATE | Corentec Co., Ltd. | 2012-05-03 | 28 | 0 |
| K110404 | EAUM TOTAL KNEE SYSTEM | Corentec Co., Ltd. | 2012-02-16 | 367 | 2 |
| K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | Corentec Co., Ltd. | 2011-10-12 | 90 | 0 |
| K103431 | COREN TOTAL HIP SYSTEM | Corentec Co., Ltd. | 2011-07-21 | 240 | 0 |
| K092076 | AEGIS & AEGIS II SPINAL SYSTEM | Corentec Co., Ltd. | 2010-04-02 | 267 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda