# Biocomposites, Ltd.

- Location (FDA's records): Keele, GB
- FDA decisions: 27 (2000–2026): 27 510(k) clearances
- Product codes: HWC (11), MQV (11), LYC (3), KWL (1), MAI (1)
- 510(k) review time since 2016: median 212 days, against 63 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 26 (7 its own); citations of its devices by later devices: 20 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Orthos (Uk) Limited: 1 (https://510kreport.com/company/orthos-uk)
- Therics, Inc.: 1 (https://510kreport.com/company/therics)
- Berkeley Advanced Biomaterials, Inc.: 1 (https://510kreport.com/company/berkeley-advanced-biomaterials)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Acu Med, Inc.: 1 (https://510kreport.com/company/acu-med)
- Howmedica Osteonics Corp.: 1 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Takiron Co., Ltd.: 3 (https://510kreport.com/company/takiron)
- Advanced Biomaterials: 2 (https://510kreport.com/company/advanced-biomaterials)
- Mitek Products: 1 (https://510kreport.com/company/mitek-products)
- Degradable Solutions AG: 1 (https://510kreport.com/company/degradable-solutions)
- Conmed Linvatec: 1 (https://510kreport.com/company/conmed-linvatec)
- Sciences For Bio Materials: 1 (https://510kreport.com/company/sciences-for-bio-materials)
- Aspine USA, Inc.: 1 (https://510kreport.com/company/aspine-usa)
- Austin Medical Ventures, Inc.: 1 (https://510kreport.com/company/austin-medical-ventures)

## Its most-cited devices
- K002070: Biolok Screw (2000), cited by 6
- K003641: Biolok Screw, Biosteon Screw (2001), cited by 4
- K021551: Stimulan - Calcium Sulfate Bone Void Filler Kit (2002), cited by 2
- K141830: Stimulan Kit, Stimulan Rapid Cure (2015), cited by 2
- K021351: Biosteon Cross Pin (2002), cited by 1
- K003954: Stimulan - Calcium Sulfate Bone Void Filler Kit (2001), cited by 1

## Recent decisions
- K251680: Biosteon® Screw (Feb 17, 2026)
- K242865: Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (Jun 12, 2025)
- K250521: NanoBone® SBX Putty ; NanoBone® QD (Apr 7, 2025)
- K212721: Genex Bone Graft Substitute (Feb 4, 2022)
- K141830: Stimulan Kit, Stimulan Rapid Cure (Jan 23, 2015)
- K082381: GENEX (Nov 14, 2008)
- K082383: Fortoss Vital (Sep 5, 2008)
- K073341: Genex Putty (Jul 9, 2008)

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