# Osartis GmbH

- Location (FDA's records): Münster, DE
- FDA decisions: 6 (2019–2024): 6 510(k) clearances
- Product codes: LOD (5), MBB (1)
- 510(k) review time since 2016: median 89 days, against 95 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 15 (0 its own); citations of its devices by later devices: 1 (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
- Heraeus Kulzer, Inc.: 4 (https://510kreport.com/company/heraeus-kulzer)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Cossington, Ltd.: 2 (https://510kreport.com/company/cossington)
- Aap Biomaterials GmbH & Co. KG: 1 (https://510kreport.com/company/aap-biomaterials)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Mandell Horwitz Consultants, LLC: 1 (https://510kreport.com/company/mandell-horwitz-consultants)
- Osteoremedies, LLC: 1 (https://510kreport.com/company/osteoremedies)
- Tecres S.P.A.: 1 (https://510kreport.com/company/tecres)

## Firms that cite its devices most
- Neo Medical SA: 1 (https://510kreport.com/company/neo-medical)

## Its most-cited devices
- K202458: BonOs Inject, Pedicle screw kits, Cement pusher (2021), cited by 1

## Recent decisions
- K240856: Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (Nov 20, 2024)
- K202458: BonOs Inject, Pedicle screw kits, Cement pusher (May 18, 2021)
- K210125: BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (Mar 19, 2021)
- K210120: BonOs HV, BonOs MV, BonOs LV (Mar 19, 2021)
- K192394: Hi-Fatigue Bone Cement (Dec 2, 2019)
- K192379: Hi-Fatigue G Bone Cement (Nov 27, 2019)

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