# Nextremity Solutions, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 20 (2011–2022): 20 510(k) clearances
- Names in FDA's records: Nextremity Solutions, Inc. (17); Nextremity Solutions, LLC (2); Nextremity Solutions (1)
- Product codes: HWC (11), HRS (6), JDR (3)
- 510(k) review time since 2016: median 92 days, against 97 for FDA's reviews in the same codes and years (8 of 14 faster)
- Predicates its devices cite: 47 (18 its own); citations of its devices by later devices: 30 (18 its own)
- Recalls linked to its devices: 13 (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)
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- Extremity Medical, LLC: 3 (https://510kreport.com/company/extremity-medical)
- Memometal Technologies: 2 (https://510kreport.com/company/memometal-technologies)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Z-Medical GmbH & Co. KG: 2 (https://510kreport.com/company/z-medical)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)

## Firms that cite its devices most
- Additive Orthopaedics, LLC: 2 (https://510kreport.com/company/additive-orthopaedics)
- Competitive Engineering, Inc.: 2 (https://510kreport.com/company/competitive-engineering)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)
- Newclip Technics: 1 (https://510kreport.com/company/newclip-technics)
- Mtp Solutions, LLC: 1 (https://510kreport.com/company/mtp-solutions)
- Graham Medical Technologies, LLC (D.B.A.Gramedica): 1 (https://510kreport.com/company/graham-medical-technologies-dbagramedica)
- Medartis AG: 1 (https://510kreport.com/company/medartis)
- Agent Medical, LLC: 1 (https://510kreport.com/company/agent-medical)

## Its most-cited devices
- K110445: Flexfusion (TM) Fixation Implant (2011), cited by 5
- K122031: Nextra TI Hammertoe Correction System (2012), cited by 5
- K182201: Stratum™ Foot Plating System (2018), cited by 4
- K131061: Restore Bunion Correction System (2013), cited by 4
- K180257: InCore® Lapidus System (2018), cited by 3
- K140724: MSP Metatarsal Shortening System (2014), cited by 3

## Recent decisions
- K221610: Nextra CH Cannulated Hammertoe System (Nov 4, 2022)
- K212979: CalcShift™ Displacement Calcaneal Osteotomy System (May 20, 2022)
- K220181: StealthFix Intraosseous Fixation System (Mar 22, 2022)
- K213301: InCore Subtalar System (Dec 21, 2021)
- K213530: Nextra CH Cannulated Hammertoe System (Dec 9, 2021)
- K212640: Stratum® Ankle Fusion Plating System (Nov 18, 2021)
- K211996: Nexta PEEK Hammertoe Correction System (Sep 23, 2021)
- K200785: Stratum™ Reduced Size Foot Plating System (Jul 27, 2020)

Source page: https://510kreport.com/company/nextremity-solutions