# Orthovita, Inc.

- Location (FDA's records): Malver, PA
- FDA decisions: 26 (1995–2017): 26 510(k) clearances
- Names in FDA's records: Orthovita, Inc. (23); Orthovita Co. (3)
- Product codes: MQV (12), FMF (4), LYC (3), KNW (2), NDN (1), HAW (1), MQP (1), ODP (1), LXH (1)
- 510(k) review time since 2016: median 131 days, against 214 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 48 (23 its own); citations of its devices by later devices: 117 (23 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Novabone Products, LLC: 3 (https://510kreport.com/company/novabone-products)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Etex Corp.: 2 (https://510kreport.com/company/etex)
- Spine Wave, Inc.: 2 (https://510kreport.com/company/spine-wave)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Teknimed, S.A.: 1 (https://510kreport.com/company/teknimed)
- Disc-O-Tech Medical Technologies, Ltd.: 1 (https://510kreport.com/company/disc-o-tech-medical-technologies)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)

## Firms that cite its devices most
- Stryker Spine: 6 (https://510kreport.com/company/stryker-spine)
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Pioneer Surgical Technology: 5 (https://510kreport.com/company/pioneer-surgical-technology)
- Titan Spine, LLC: 4 (https://510kreport.com/company/titan-spine)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Collagen Matrix, Inc.: 3 (https://510kreport.com/company/collagen-matrix)
- Osteobiologics, Inc.: 3 (https://510kreport.com/company/osteobiologics)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler (2000), cited by 26
- K032288: Vitoss Scaffold Foam Bone Graft Material (2003), cited by 17
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), cited by 11
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler (2003), cited by 8
- K030208: Imbibe II Syringe (2003), cited by 7
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), cited by 6

## Recent decisions
- K163621: Vitoss Bioactive (BA) Injectable (May 2, 2017)
- K161447: HydroSet XT (Oct 6, 2016)
- K153608: Vitoss BiModal Bone Graft Substitute Foam Strip (Feb 12, 2016)
- K153306: Imbibe Needle (Dec 18, 2015)
- K140868: Stryker Kwic Needle (Jun 5, 2014)
- K140414: Imbibe Needle (Apr 1, 2014)
- K103173: Vitoss BA Bimodal Bioactive Bone Graft Substitute (Feb 7, 2011)
- K101171: Orthovita Peek Spacer (Jan 25, 2011)

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