Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osteonic Co., Ltd. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
210 daysmedian FDA review time
378 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 | 65 | 0 |
| K243469 | SIGNEX | Osteonic Co., Ltd. | 2025-05-29 | 202 | 0 |
| K243470 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2024-12-03 | 25 | 0 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocomb | Osteonic Co., Ltd. | 2024-12-03 | 25 | 0 |
| K230546 | SIGNEX | Osteonic Co., Ltd. | 2024-06-11 | 469 | 0 |
| K233659 | Suture Wing | Osteonic Co., Ltd. | 2023-12-26 | 41 | 0 |
| K231322 | Fix2Lock(PEEK Self Punching) | Osteonic Co., Ltd. | 2023-06-07 | 30 | 0 |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punchin | Osteonic Co., Ltd. | 2023-05-31 | 23 | 0 |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A | Osteonic Co., Ltd. | 2022-01-27 | 353 | 0 |
| K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021-10-15 | 109 | 0 |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Osteonic Co., Ltd. | 2021-08-27 | 220 | 0 |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocomb | Osteonic Co., Ltd. | 2021-06-17 | 267 | 0 |
| K202663 | Suture Wing | Osteonic Co., Ltd. | 2021-06-07 | 266 | 0 |
| K202763 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2021-06-04 | 256 | 0 |
| K202883 | Sterile bone screw (PEEK ACL screw) | Osteonic Co., Ltd. | 2020-11-25 | 58 | 0 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019-11-27 | 243 | 0 |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019-01-02 | 30 | 0 |
| K160363 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | 2016-10-20 | 254 | 0 |
| K141911 | OPTIMUS NEURO SYSTEM | Osteonic Co., Ltd. | 2015-02-10 | 210 | 0 |
| K140037 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | 2015-01-20 | 378 | 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