| Aster (K254182) | Osteonic Co., Ltd. | 2026-02-26 |
| SIGNEX (K243469) | Osteonic Co., Ltd. | 2025-05-29 |
| Fix2Lock (PEEK Self Punching) (K243470) | Osteonic Co., Ltd. | 2024-12-03 |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K243467) | Osteonic Co., Ltd. | 2024-12-03 |
| SIGNEX (K230546) | Osteonic Co., Ltd. | 2024-06-11 |
| Suture Wing (K233659) | Osteonic Co., Ltd. | 2023-12-26 |
| Fix2Lock(PEEK Self Punching) (K231322) | Osteonic Co., Ltd. | 2023-06-07 |
| Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (K231326) | Osteonic Co., Ltd. | 2023-05-31 |
| Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) (K210360) | Osteonic Co., Ltd. | 2022-01-27 |
| Ortho MI System (K211992) | Osteonic Co., Ltd. | 2021-10-15 |
| Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (K210122) | Osteonic Co., Ltd. | 2021-08-27 |
| Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K202806) | Osteonic Co., Ltd. | 2021-06-17 |
| Suture Wing (K202663) | Osteonic Co., Ltd. | 2021-06-07 |
| Fix2Lock (PEEK Self Punching) (K202763) | Osteonic Co., Ltd. | 2021-06-04 |
| Sterile bone screw (PEEK ACL screw) (K202883) | Osteonic Co., Ltd. | 2020-11-25 |
| Optimus NEURO System - Sterile Kit (K190811) | Osteonic Co., Ltd. | 2019-11-27 |
| Optimus Neuro System (K183352) | Osteonic Co., Ltd. | 2019-01-02 |
| OPTIMUS CMF SYSTEM (K160363) | Osteonic Co., Ltd. | 2016-10-20 |
| OPTIMUS NEURO SYSTEM (K141911) | Osteonic Co., Ltd. | 2015-02-10 |
| OPTIMUS CMF SYSTEM (K140037) | Osteonic Co., Ltd. | 2015-01-20 |