# Bone Solutions, Inc.

- Location (FDA's records): Colleyville, TX
- FDA decisions: 9 (2009–2026): 9 510(k) clearances
- Product codes: MQV (7), FMF (2)
- 510(k) review time since 2016: median 87 days, against 102 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 19 (8 its own); citations of its devices by later devices: 10 (8 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
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Bonalive Biomaterials, Ltd.: 2 (https://510kreport.com/company/bonalive-biomaterials)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Kensey Nash Corporation Dba Dsm Biomedical: 1 (https://510kreport.com/company/kensey-nash-dba-dsm-biomedical)
- Nexa Orthopedics, Inc.: 1 (https://510kreport.com/company/nexa-orthopedics)
- Bonesupport AB: 1 (https://510kreport.com/company/bonesupport)
- Etex Corp.: 1 (https://510kreport.com/company/etex)
- Ossdsign AB: 1 (https://510kreport.com/company/ossdsign)

## Firms that cite its devices most
- SurGenTec, LLC: 1 (https://510kreport.com/company/surgentec)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)

## Its most-cited devices
- K161568: Bone Solutions Mixing and Delivery System (2016), cited by 3
- K242372: Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (2024), cited by 2
- K234013: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg  OSTEOCRETE™ (2024), cited by 2
- K212991: Osteorevive (2022), cited by 1
- K071004: Osteocrete Bone Void Filler (2009), cited by 1
- K251522: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (2025), cited by 1

## Recent decisions
- K262230: Mg OSTEOREVIVE™;Mg OSTEOCRETE™ (Sep 11, 2026)
- K251522: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (Oct 13, 2025)
- K242372: Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (Oct 18, 2024)
- K234013: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg  OSTEOCRETE™ (Feb 5, 2024)
- K221256: Mg OSTEOINJECT (Jun 28, 2022)
- K212991: Osteorevive (Jan 21, 2022)
- K192674: Mixing and Delivery System (Feb 18, 2020)
- K161568: Bone Solutions Mixing and Delivery System (Sep 16, 2016)

Source page: https://510kreport.com/company/bone-solutions