# Axya Medical, Inc.

- Location (FDA's records): Beverly, MA
- FDA decisions: 19 (1998–2007): 19 510(k) clearances
- Product codes: GAW (5), MBI (5), MAI (3), GAT (3), GAB (1), JDR (1), LFL (1)
- Predicates its devices cite: 35 (15 its own); citations of its devices by later devices: 26 (15 its own)
- Recalls linked to its devices: 21 (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)
- Synergistic Medical Technologies, Inc.: 3 (https://510kreport.com/company/synergistic-medical-technologies)
- Mitek Worldwide: 2 (https://510kreport.com/company/mitek-worldwide)
- Genzyme Surgical Product (Genzyme Biosurgery): 2 (https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery)
- Mitek Products: 1 (https://510kreport.com/company/mitek-products)
- Innovasive Devices, Inc.: 1 (https://510kreport.com/company/innovasive-devices)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Ultracision, Inc.: 1 (https://510kreport.com/company/ultracision)

## Firms that cite its devices most
- Tornier, Inc.: 6 (https://510kreport.com/company/tornier)
- Suspension Orthopaedic Solutions, LLC: 2 (https://510kreport.com/company/suspension-orthopaedic-solutions)
- Simparo, Inc.: 1 (https://510kreport.com/company/simparo)
- Foosin Medical Supplies Inc., Ltd.: 1 (https://510kreport.com/company/foosin-medical-supplies)
- Biocomposites, Ltd.: 1 (https://510kreport.com/company/biocomposites)

## Its most-cited devices
- K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor (2004), cited by 5
- K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) (1998), cited by 3
- K060970: Axyaloop Nonabsorbable Bone Anchor (2006), cited by 3
- K983108: Suture Welding System and Kit (SWK) (1998), cited by 3
- K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor (2005), cited by 2
- K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 (2001), cited by 2

## Recent decisions
- K070773: Axya, Model 3000  Axyzloop Titanium Bone Anchor (Oct 11, 2007)
- K070253: Axya Suture Welding System and Kit (Jul 11, 2007)
- K063194: Tufflex Polyester Suture (Dec 4, 2006)
- K060165: Axyaflex Polyester Suture (Sep 1, 2006)
- K060970: Axyaloop Nonabsorbable Bone Anchor (Jul 5, 2006)
- K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor (Oct 7, 2005)
- K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor (Aug 5, 2005)
- K051250: Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor (Jun 9, 2005)

Source page: https://510kreport.com/company/axya-medical