Osteonic Co., Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Osteonic Co., Ltd.” (first 2015, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 109 days, against 89 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 |
|---|---|---|
| 2015 | 2 | 294 |
| 2016 | 1 | 254 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 136 |
| 2020 | 1 | 58 |
| 2021 | 5 | 256 |
| 2022 | 1 | 353 |
| 2023 | 3 | 30 |
| 2024 | 3 | 25 |
| 2025 | 1 | 202 |
| 2026 | 1 | 65 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osteonic Co., Ltd. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 6 | 6 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 4 | 4 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 4 | 4 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JEY | Plate, Bone | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Orthopedic (13)
- Neurology (4)
- Dental (3)
Most recent Osteonic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254182 | Aster | KWQ | 2026-02-26 | 65 |
| K243469 | SIGNEX | HRS | 2025-05-29 | 202 |
| K243470 | Fix2Lock (PEEK Self Punching) | MBI | 2024-12-03 | 25 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | MAI | 2024-12-03 | 25 |
| K230546 | SIGNEX | HRS | 2024-06-11 | 469 |
| K233659 | Suture Wing | MBI | 2023-12-26 | 41 |
| K231322 | Fix2Lock(PEEK Self Punching) | MBI | 2023-06-07 | 30 |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | MAI | 2023-05-31 | 23 |
| K210360 | 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) | GWO | 2022-01-27 | 353 |
| K211992 | Ortho MI System | OAT | 2021-10-15 | 109 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteonic Co., Ltd..
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 Osteonic Co., Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Osteonic Co., Ltd.” (first 2015, latest 2026), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Osteonic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteonic Co., Ltd. is 206 days. Since 2017: 109 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osteonic Co., Ltd.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 6); GWO (Plate, Cranioplasty, Preformed, Alterable, 4); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 4).
Next steps
- See all 20 Osteonic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Osteonic 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.