# Instratek, Inc.

- Location (FDA's records): Houston, TX
- FDA decisions: 10 (1992–2014): 10 510(k) clearances
- Product codes: HRX (3), HTN (3), HWC (3), JDR (1)
- Predicates its devices cite: 24 (2 its own); citations of its devices by later devices: 17 (2 its own)
- Recalls linked to its devices: 16 (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)
- Vilex, LLC: 4 (https://510kreport.com/company/vilex)
- Osteomed LP: 3 (https://510kreport.com/company/osteomed)
- Kinetikos Medical, Inc.: 3 (https://510kreport.com/company/kinetikos-medical)
- Memometal Technologies: 2 (https://510kreport.com/company/memometal-technologies)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Nexa Orthopedics, Inc.: 1 (https://510kreport.com/company/nexa-orthopedics)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Dev4: 2 (https://510kreport.com/company/dev4)
- Mondeal North America, Inc.: 2 (https://510kreport.com/company/mondeal-north-america)
- Cycla Orthopedics, Ltd.: 1 (https://510kreport.com/company/cycla-orthopedics)
- Ascent Medical, LLC: 1 (https://510kreport.com/company/ascent-medical)
- Acumed, LLC: 1 (https://510kreport.com/company/acumed)
- Restore Surgical, LLC Dba Instratek: 1 (https://510kreport.com/company/restore-surgical-dba-instratek)
- Fusion Orthopedics, LLC: 1 (https://510kreport.com/company/fusion-orthopedics)
- GM Dos Reis Industria e Comercio Ltda.: 1 (https://510kreport.com/company/gm-dos-reis-industria-e-comercio)

## Its most-cited devices
- K080280: Sub-Talar Lok, Model 7-11 MM (2008), cited by 5
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), cited by 4
- K091763: Michelangelo Bunion System - Mabs, Model: MA6000 (2009), cited by 2
- K925083: Endotrak System (1993), cited by 1
- K111032: CMC Cable Fix (2011), cited by 1
- K922391: Endoscopic Carpal Tunnel Instruments (1992), cited by 1

## Recent decisions
- K133523: Stapix Superelastic Implant Bone Staples (Feb 6, 2014)
- K131620: Jones-FX Fracture System (Jul 25, 2013)
- K120493: Mini Cannulated Headed and Headless Screw Set (May 17, 2012)
- K111032: CMC Cable Fix (Aug 31, 2011)
- K091763: Michelangelo Bunion System - Mabs, Model: MA6000 (Aug 14, 2009)
- K082384: Hav-Lok Bunion Correction System (Dec 8, 2008)
- K080280: Sub-Talar Lok, Model 7-11 MM (Mar 14, 2008)
- K940230: Endoscopic Mortons Neuroma Instruments (Dec 12, 1994)

Source page: https://510kreport.com/company/instratek