# Bionx Implants, Inc.

- Location (FDA's records): Tampere, FI
- FDA decisions: 30 (1998–2003): 30 510(k) clearances
- Names in FDA's records: Bionx Implants, Inc. (18); Bionx Implants, Ltd. (12)
- Product codes: MAI (11), HWC (10), JEY (7), HTY (2)
- Predicates its devices cite: 118 (32 its own); citations of its devices by later devices: 78 (32 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
- Arthrex, Inc.: 10 (https://510kreport.com/company/arthrex)
- Linvatec Corp.: 9 (https://510kreport.com/company/linvatec)
- Synthes (Usa): 7 (https://510kreport.com/company/synthes-usa)
- Bioscience, Inc.: 7 (https://510kreport.com/company/bioscience)
- Biomet, Inc.: 6 (https://510kreport.com/company/biomet)
- Innovasive Devices, Inc.: 6 (https://510kreport.com/company/innovasive-devices)
- Instrument Makar, Inc.: 5 (https://510kreport.com/company/instrument-makar)
- Depuy, Inc.: 4 (https://510kreport.com/company/depuy)

## Firms that cite its devices most
- Linvatec Biomaterials, Ltd.: 19 (https://510kreport.com/company/linvatec-biomaterials)
- Xtremi-T, LLC: 7 (https://510kreport.com/company/xtremi-t)
- Inion, Ltd.: 4 (https://510kreport.com/company/inion)
- Takiron Co., Ltd.: 3 (https://510kreport.com/company/takiron)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Arc Surgical, LLC: 2 (https://510kreport.com/company/arc-surgical)
- Conmed Linvatec: 2 (https://510kreport.com/company/conmed-linvatec)
- KLS-Martin L.P.: 1 (https://510kreport.com/company/kls-martin)

## Its most-cited devices
- K003077: Smartscrew Model 222006...227510 (2001), cited by 10
- K974876: Bionx Distal Radius Screw (1998), cited by 8
- K012001: Smartscrew (2001), cited by 6
- K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 (1999), cited by 5
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), cited by 5
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), cited by 5

## Recent decisions
- K030388: Impact Suture Anchor. Model 433510 (Apr 24, 2003)
- K023022: Nugen FX Screw (Oct 4, 2002)
- K020056: Duet Suture Anchor (Jun 26, 2002)
- K011569: Biosorbfx O/M 2.0/2/4 System (Feb 22, 2002)
- K013546: Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 (Nov 21, 2001)
- K013057: Biocuff,C, Models 236018, 236028, 236036 (Oct 12, 2001)
- K012334: Contour Meniscus Arrow, Models 541110, 541113, and 541116 (Sep 19, 2001)
- K012001: Smartscrew (Jul 18, 2001)

Source page: https://510kreport.com/company/bionx-implants