# Bioretec, Ltd.

- Location (FDA's records): Tampere, FI
- FDA decisions: 10 (2006–2026): 9 510(k) clearances and 1 De Novo grant
- Product codes: HTY (4), HWC (4), QJD (1), MAI (1)
- Predicates its devices cite: 22 (10 its own); citations of its devices by later devices: 12 (10 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
- Inion, Ltd.: 6 (https://510kreport.com/company/inion)
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Bionx Implants, Inc.: 1 (https://510kreport.com/company/bionx-implants)

## Firms that cite its devices most
- Extremity Medical, LLC: 1 (https://510kreport.com/company/extremity-medical)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)

## Its most-cited devices
- K061164: Activapin (2006), cited by 6
- K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin (2008), cited by 2
- K072848: Activascrew (2007), cited by 2
- K062980: Activascrew (2006), cited by 1
- K080879: Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm (2008), cited by 1

## Recent decisions
- K261057: ActivaScrew™ Cannulated COM (Sep 4, 2026)
- DEN220030: RemeOs™ Screw LAG Solid (Mar 29, 2023)
- K133950: Activapin HT, Fuse Link (Private Labled for Footmind, Inc.) (Jan 22, 2014)
- K130716: Bioretec Activascrew Interference (Aug 28, 2013)
- K080879: Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm (Jun 24, 2008)
- K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin (Jun 18, 2008)
- K072848: Activascrew (Nov 2, 2007)
- K071863: Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS) (Aug 31, 2007)

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