# Orthohelix Surgical Designs, Inc.

- Location (FDA's records): Medina, OH
- FDA decisions: 25 (2005–2014): 25 510(k) clearances
- Product codes: HRS (17), HWC (3), JDR (2), HTY (2), HTN (1)
- Predicates its devices cite: 66 (28 its own); citations of its devices by later devices: 66 (28 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Osteonics Corp.: 9 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Memometal Technologies: 4 (https://510kreport.com/company/memometal-technologies)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Biomedical Ent., Inc.: 2 (https://510kreport.com/company/biomedical-ent)
- Small Bone Innovations, Inc.: 1 (https://510kreport.com/company/small-bone-innovations)
- Acu Med, Inc.: 1 (https://510kreport.com/company/acu-med)

## Firms that cite its devices most
- MiRus, LLC: 4 (https://510kreport.com/company/mirus)
- Extremity Medical, LLC: 3 (https://510kreport.com/company/extremity-medical)
- Life Spine, Inc.: 3 (https://510kreport.com/company/life-spine)
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- CarboFix Orthopedics, Ltd.: 3 (https://510kreport.com/company/carbofix-orthopedics)
- Paragon 28, Inc.: 3 (https://510kreport.com/company/paragon-28)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Treace Medical Concepts, Inc.: 2 (https://510kreport.com/company/treace-medical-concepts)

## Its most-cited devices
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), cited by 8
- K101962: Mini Maxlock Extreme Plating System (2010), cited by 7
- K120157: Mini Maxlock Extreme Plating System (2012), cited by 7
- K073624: Modular Foot System (2008), cited by 5
- K121437: Mini Maxlock Extreme Plating System (2012), cited by 4
- K113048: Maxlock Extreme System (2012), cited by 4

## Recent decisions
- K141004: Intraosseous Fixation System (Aug 21, 2014)
- K142148: Orthohelix Staple System (Aug 21, 2014)
- K141301: Maxlock Extreme Elbow Fracture System (Jul 11, 2014)
- K132733: Orthohelix Syndesmosis Fixation Devices (Jan 3, 2014)
- K132591: Maxlock Extreme System (Sep 17, 2013)
- K130832: Orthohelix Staple System (Aug 15, 2013)
- K131324: Maxtorque Screw System (May 31, 2013)
- K123203: Maxlock Extreme System Model MXL (Dec 14, 2012)

Source page: https://510kreport.com/company/orthohelix-surgical-designs