# Vilex, LLC

- Location (FDA's records): Mcminnville, TN
- FDA decisions: 30 (1998–2026): 30 510(k) clearances
- Names in FDA's records: Vilex, LLC (17); Vilex, Inc. (13)
- Product codes: HWC (9), KTT (5), HRS (4), KWD (3), JDR (2), HTN (2), HSB (2), HSN (2), JDW (1)
- 510(k) review time since 2016: median 110 days, against 112 for FDA's reviews in the same codes and years (7 of 17 faster)
- Predicates its devices cite: 66 (21 its own); citations of its devices by later devices: 92 (21 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 6 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Paragon 28, Inc.: 4 (https://510kreport.com/company/paragon-28)
- Orthofix, Inc.: 4 (https://510kreport.com/company/orthofix)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Vilex IN Tennessee, Inc.: 3 (https://510kreport.com/company/vilex-in-tennessee)
- Dt Medtech, LLC: 2 (https://510kreport.com/company/dt-medtech)
- Stryker Howmedica Osteonics: 2 (https://510kreport.com/company/stryker-howmedica-osteonics)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)

## Firms that cite its devices most
- Vilex IN Tennessee, Inc.: 7 (https://510kreport.com/company/vilex-in-tennessee)
- Nvision Biomedical Technologies, Inc.: 5 (https://510kreport.com/company/nvision-biomedical-technologies)
- Solana Surgical, LLC: 4 (https://510kreport.com/company/solana-surgical)
- Instratek, Inc.: 4 (https://510kreport.com/company/instratek)
- Apogee Orthosolutions: 4 (https://510kreport.com/company/apogee-orthosolutions)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- Accufix Surgical, Inc.: 3 (https://510kreport.com/company/accufix-surgical)
- Paragon 28, Inc.: 2 (https://510kreport.com/company/paragon-28)

## Its most-cited devices
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00 (2002), cited by 16
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 (1999), cited by 14
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw (1999), cited by 10
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation (2007), cited by 7
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 (2004), cited by 6
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw (1998), cited by 6

## Recent decisions
- K260900: DYNEX® External Fixation Systems (Apr 17, 2026)
- K250304: TITANEX Screw Systems (Mar 5, 2025)
- K240475: Hintermann Series H2 Total Ankle System (Dec 2, 2024)
- K243408: TACTIX Vector Syndesmosis System (Nov 27, 2024)
- K233816: REDEMPTION Charcot Plating System (Aug 28, 2024)
- K240035: TACTIX Vector Syndesmosis System (Aug 1, 2024)
- K231343: Redemption Duo Hindfoot Nail System (Jan 30, 2024)
- K231504: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System (Sep 11, 2023)

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