# Linvatec Biomaterials, Ltd.

- Location (FDA's records): Tampere, FI
- FDA decisions: 8 (2003–2005): 8 510(k) clearances
- Names in FDA's records: Linvatec Biomaterials, Ltd. (5); Linvatec Biomaterials, Inc. (3)
- Product codes: HWC (4), MAI (2), JEY (1), HTY (1)
- Predicates its devices cite: 29 (2 its own); citations of its devices by later devices: 14 (2 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
- Bionx Implants, Inc.: 19 (https://510kreport.com/company/bionx-implants)
- Linvatec Corp.: 3 (https://510kreport.com/company/linvatec)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Encore Orthopedics, Inc.: 1 (https://510kreport.com/company/encore-orthopedics)
- Biocomposites, Ltd.: 1 (https://510kreport.com/company/biocomposites)
- Davis & Geck, Inc.: 1 (https://510kreport.com/company/davis-geck)
- Bioscience, Inc.: 1 (https://510kreport.com/company/bioscience)

## Firms that cite its devices most
- Conmed Linvatec: 4 (https://510kreport.com/company/conmed-linvatec)
- Xtremi-T, LLC: 2 (https://510kreport.com/company/xtremi-t)
- Takiron Co., Ltd.: 1 (https://510kreport.com/company/takiron)
- Arc Surgical, LLC: 1 (https://510kreport.com/company/arc-surgical)
- Linvatec Corp.: 1 (https://510kreport.com/company/linvatec)
- Advanced Biomaterials: 1 (https://510kreport.com/company/advanced-biomaterials)
- Conmed Linvatec Biomaterials: 1 (https://510kreport.com/company/conmed-linvatec-biomaterials)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Its most-cited devices
- K052080: Matryx Interference Screw (2005), cited by 4
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), cited by 3
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), cited by 2
- K041288: Modification to Smartpin (2004), cited by 2
- K042295: Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020 (2004), cited by 1
- K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445 (2003), cited by 1

## Recent decisions
- K052080: Matryx Interference Screw (Aug 25, 2005)
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (Nov 19, 2004)
- K042517: Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws (Oct 8, 2004)
- K042295: Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020 (Sep 16, 2004)
- K041288: Modification to Smartpin (Jun 10, 2004)
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (May 7, 2004)
- K032447: Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded (Apr 16, 2004)
- K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445 (Jul 25, 2003)

Source page: https://510kreport.com/company/linvatec-biomaterials