# B-One Ortho, Corp.

- Location (FDA's records): Cedar Knolls, NJ
- FDA decisions: 13 (2018–2026): 13 510(k) clearances
- Product codes: JWH (7), LZO (4), MAI (1), KWY (1)
- 510(k) review time since 2016: median 75 days, against 100 for FDA's reviews in the same codes and years (3 of 12 faster)
- Predicates its devices cite: 20 (6 its own); citations of its devices by later devices: 6 (6 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
- Aju Pharm Co., Ltd.: 5 (https://510kreport.com/company/aju-pharm)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Osteonics Corp.: 1 (https://510kreport.com/company/osteonics)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)

## Its most-cited devices
- K202429: Mobio Total Knee System (2020), cited by 2
- K222431: b-ONER MOBIO Total Knee System (2022), cited by 1
- K180446: b-ONE Total Knee System (2018), cited by 1
- K202768: KOSMO Femoral Stem (2021), cited by 1
- K210483: MOBIO Total Knee System (2021), cited by 1

## Recent decisions
- K262341: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions (Sep 8, 2026)
- K253357: b-ONE® Bipolar Head (Apr 13, 2026)
- K240528: b-ONE® Total Hip System (Nov 15, 2024)
- K222431: b-ONER MOBIO Total Knee System (Oct 6, 2022)
- K213673: b-ONE MOBIO Total Knee System (Jan 21, 2022)
- K212912: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (Nov 4, 2021)
- K210483: MOBIO Total Knee System (Apr 21, 2021)
- K202768: KOSMO Femoral Stem (Apr 1, 2021)

Source page: https://510kreport.com/company/b-one-ortho