# Bioventus, LLC

- Location (FDA's records): Durham, NC
- FDA decisions: 9 (1994–2026): 7 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Bioventus, LLC (8); Bioventus (1)
- Product codes: MQV (3), GZF (3), LOF (1), FMF (1), MOZ (1)
- 510(k) review time since 2016: median 153 days, against 127 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 13 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biostructures, LLC: 3 (https://510kreport.com/company/biostructures)
- Bioness, Inc.: 2 (https://510kreport.com/company/bioness)
- Boston Scientific Neuromodulation: 2 (https://510kreport.com/company/boston-scientific-neuromodulation)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Advanced Neuromodulation Systems: 1 (https://510kreport.com/company/advanced-neuromodulation-systems)
- Spinal Surgical Strategies, LLC: 1 (https://510kreport.com/company/spinal-surgical-strategies)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)

## Firms that cite its devices most
- Kuros Biosciences: 1 (https://510kreport.com/company/kuros-biosciences)

## Its most-cited devices
- K233490: SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (2023), cited by 1

## Recent decisions
- K253877: StimTrial Neuromodulation System (Aug 26, 2026)
- K243782: StimTrial Neuromodulation System (Jul 16, 2025)
- K243678: TalisMann Neuromodulation System (Jul 3, 2025)
- K233368: Allograft Delivery Device (OFAC-C) (Jun 25, 2024)
- K233490: SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (Dec 5, 2023)
- K193513: SIGNAFUSE Bioactive Bone Graft (Jun 18, 2020)
- P170007: Durolane (Aug 29, 2017)
- K162860: MCS Bone Graft (Feb 13, 2017)

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