# Safe Orthopaedics

- Location (FDA's records): Eragny Sur Oise, FR
- FDA decisions: 13 (2011–2020): 13 510(k) clearances
- Product codes: NKB (9), MAX (3), OVE (1)
- 510(k) review time since 2016: median 42 days, against 69 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 40 (30 its own); citations of its devices by later devices: 32 (30 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Interpore Cross Intl.: 2 (https://510kreport.com/company/interpore-cross-intl)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Zavation, LLC: 1 (https://510kreport.com/company/zavation)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Centinel Spine, Inc.: 1 (https://510kreport.com/company/centinel-spine)

## Firms that cite its devices most
- Neo Medical SA: 1 (https://510kreport.com/company/neo-medical)
- Kyocera Medical Technologies Inc. (KMTI): 1 (https://510kreport.com/company/kyocera-medical-technologies-kmti)

## Its most-cited devices
- K112453: Sterispineps Pedicle Screw (2011), cited by 9
- K121299: Sterispineps Pedicle Screw, Sterispineps Rod (2012), cited by 5
- K130632: Sterispine PS Pedicle Screw (2013), cited by 4
- K140802: Sterispine PS (2014), cited by 3
- K151747: Sterispine PS (2015), cited by 2
- K150092: STERISPINE PS Pedicle Screw (2015), cited by 2

## Recent decisions
- K201648: Sterispine™ PS (Jul 30, 2020)
- K170528: Sterispine™ PS (Mar 9, 2017)
- K162531: Sterispine CC (Dec 29, 2016)
- K151921: Sterispine PS (Oct 8, 2015)
- K151747: Sterispine PS (Oct 5, 2015)
- K151756: Sterispine LC Cage (Aug 21, 2015)
- K150092: STERISPINE PS Pedicle Screw (Feb 10, 2015)
- K140802: Sterispine PS (Jun 4, 2014)

Source page: https://510kreport.com/company/safe-orthopaedics