# Osteonic Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 20 (2015–2026): 20 510(k) clearances
- Product codes: MBI (6), MAI (4), GWO (4), HRS (2), JEY (2), KWQ (1), OAT (1)
- 510(k) review time since 2016: median 87 days, against 93 for FDA's reviews in the same codes and years (9 of 16 faster)
- Predicates its devices cite: 54 (13 its own); citations of its devices by later devices: 15 (13 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 16 (https://510kreport.com/company/synthes-usa)
- Medartis AG: 6 (https://510kreport.com/company/medartis)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- Biomet Microfixation: 2 (https://510kreport.com/company/biomet-microfixation)
- Jeil Medical Corporation: 2 (https://510kreport.com/company/jeil-medical)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Aju Pharm Co., Ltd.: 1 (https://510kreport.com/company/aju-pharm)
- Acumed, LLC: 1 (https://510kreport.com/company/acumed)

## Firms that cite its devices most
- Mci Medical Concept Innovation, Inc.: 1 (https://510kreport.com/company/mci-medical-concept-innovation)
- Southern Medical (Pty), Ltd.: 1 (https://510kreport.com/company/southern-medical)

## Its most-cited devices
- K141911: Optimus Neuro System (2015), cited by 3
- K202806: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (2021), cited by 2
- K230546: Signex (2024), cited by 2
- K140037: Optimus CMF System (2015), cited by 2
- K231326: Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching) (2023), cited by 1
- K202663: Suture Wing (2021), cited by 1

## Recent decisions
- K254182: Aster (Feb 26, 2026)
- K243469: Signex (May 29, 2025)
- K243467: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (Dec 3, 2024)
- K243470: Fix2Lock (PEEK Self Punching) (Dec 3, 2024)
- K230546: Signex (Jun 11, 2024)
- K233659: Suture Wing (Dec 26, 2023)
- K231322: Fix2Lock (PEEK Self Punching) (Jun 7, 2023)
- K231326: Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching) (May 31, 2023)

Source page: https://510kreport.com/company/osteonic