# Otis Biotech Co., Ltd.

- Location (FDA's records): Siheung-Si, Gyounggi-Do, KR
- FDA decisions: 3 (2009–2017): 3 510(k) clearances
- Product codes: MNH (1), LZO (1), JWH (1)
- Predicates its devices cite: 19 (0 its own); citations of its devices by later devices: 2 (0 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
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Osteonics Corp.: 2 (https://510kreport.com/company/osteonics)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Bk Meditech, Co., Ltd.: 1 (https://510kreport.com/company/bk-meditech)
- Jemo Spine, LLC: 1 (https://510kreport.com/company/jemo-spine)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)

## Firms that cite its devices most
- Tjc Life Co., Ltd.: 1 (https://510kreport.com/company/tjc-life)
- Surgtech, Inc.: 1 (https://510kreport.com/company/surgtech)

## Its most-cited devices
- K170534: Prolixus Total Knee System (2017), cited by 2

## Recent decisions
- K170534: Prolixus Total Knee System (Nov 9, 2017)
- K101472: Multifit Total Hip System (Jan 5, 2011)
- K083077: Ulc Spinal Pedicle Screw System (Oct 26, 2009)

Source page: https://510kreport.com/company/otis-biotech