Vilex LLC

FDA Device Registration & Listing · MCMINNVILLE, TN, US · Registration 1051526

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1051526
FEI Number
1051526
Entity Name
Vilex LLC
City/State/Country
MCMINNVILLE, TN, US
Establishment Address
111 MOFFITT ST, MCMINNVILLE, TN 37110, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Vilex LLC (Owner Number: 1051526)
Owner / Operator Contact Address
111 MOFFITT STREET, --, Mc Minnville, TN 37110, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K202054
PMA Number
N/A

All Registered Proprietary Names

OPTIX H2 Patient Specific Instrument System Small Bone Implant System Hintermann Series H2 Total Ankle System Jones Fracture TITANEX ARTEMIS Screw System TITANEX MICROBEAM Screw System VILEX BONE PLATE SYSTEM AVID Plate System VILEX EZ-FIX Orthex TITANEX Screw Systems Blade Handle, Vilex EPF/MEND LAG SCREW - TITANIUM/STAINLESS VILEX FUZE SYSTEM Electric Power Unit and accessories for small bone surgery CANNULATED HEMI TOE IMPLANT CHUCK ECO DRIVER W REDEMPTION DUO Hindfoot Nail System DYNEX External Fixation Systems Hintermann Series H2 Total Ankle System DUAL THREAD BONE SCREW Titanex II ALPHALOK Plating System MET-HEAD IMPLANT HammerFuze Talex TALUS OF VILEX (TOV) TACTIX Vector Syndesmosis System Cannulated Driver Titanex, Lag Screw - Titanium/Stainless REDEMPTION Beaming System CANNULATED HEMI TOE IMPLANT - HA COATING Nitinex Vilex Memory Staple ALPHALOK Plating System Dynex Ring Fixation System Diametrix Ring Fixation System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OYK Ankle Arthroplasty Implantation System Orthopedic Class 2 888.3110 2024-02-22
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-02-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-11-02
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2025-05-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-07-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-07-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2008-11-03
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2008-11-03
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2016-09-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-09-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-05-15
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2023-07-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-03
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-07-13
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 1992-06-23
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2008-11-03
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 1997-09-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-02-22
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2026-04-21
PIN Kidney Perfusion Kit Gastroenterology, Urology Class 2 876.5880 2026-04-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2026-04-21
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2025-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-07-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-12
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2008-11-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-10-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-10-30
HXX Screwdriver Orthopedic Class 1 888.4540 1992-06-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-12
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2011-11-09
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2012-10-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-07-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-07-12
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-10-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2020-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vilex LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2022 Exactech, Inc. 2
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1051526. Last updated year: 2026. Please use registration number 1051526 when referencing this establishment in official correspondence.
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