# Auxein Medical Private Limited

- Location (FDA's records): Sonipat, IN
- FDA decisions: 12 (2020–2023): 12 510(k) clearances
- Product codes: HRS (4), MBI (4), HWC (2), JDS (1), KTT (1)
- 510(k) review time since 2016: median 355 days, against 84 for FDA's reviews in the same codes and years (0 of 12 faster)
- Predicates its devices cite: 30 (1 its own); citations of its devices by later devices: 5 (1 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
- Synthes (Usa): 15 (https://510kreport.com/company/synthes-usa)
- Parcus Medical, LLC: 4 (https://510kreport.com/company/parcus-medical)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- Advanced Orthopaedic Solutions, Inc.: 1 (https://510kreport.com/company/advanced-orthopaedic-solutions)
- Aap Implantate AG: 1 (https://510kreport.com/company/aap-implantate)
- Depuy Mitek: 1 (https://510kreport.com/company/depuy-mitek)

## Firms that cite its devices most
- Tdm Co., Ltd.: 2 (https://510kreport.com/company/tdm)
- Auxein Medical Pvt., Ltd.: 2 (https://510kreport.com/company/auxein-medical-pvt)

## Its most-cited devices
- K213059: Tibia and Fibula System (2023), cited by 2
- K192003: Auxein Nailing System (2020), cited by 2
- K213108: Humerus & Ulna System (2022), cited by 1

## Recent decisions
- K221787: Auxein's DHS/DCS Plate System (Nov 30, 2023)
- K213059: Tibia and Fibula System (Jan 27, 2023)
- K213110: AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor (Dec 16, 2022)
- K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate (Nov 18, 2022)
- K213108: Humerus & Ulna System (Nov 4, 2022)
- K213014: Varixis Elbow System (Oct 3, 2022)
- K213109: Auxilock Draw Tight Suture-Based Anchor (Aug 22, 2022)
- K213104: Auxilock Titanium Screw-In Suture Anchor (Jul 29, 2022)

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