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Data / Medical devices / United States / Vilex LLC

Vilex LLC: FDA-registered device maker in Mcminnville, TN, United States, 31 510(k) clearances

Vilex LLC is registered with the FDA (registration 1051526) in Mcminnville, TN, United States. It lists 31 device types. The FDA files 31 510(k) clearances under its listings, the newest dated April 17, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Vilex LLC
FDA registration number
1051526
Address
111 Moffitt ST, Mcminnville, TN, United States, 37110
Owner or operator
Vilex LLC (1051526)
Roles
Manufacturer, Repackager or relabeler
First device listed
April 26, 1991
Registered through
2026
Brand names listed
ALPHALOK Plating System, AVID Plate System, Blade Handle, Vilex EPF/MEND, Blade, Vilex EPF/MEND, Burrs for power accessories, CANNULATED HEMI TOE IMPLANT, CANNULATED HEMI TOE IMPLANT - HA COATING, CHUCK and more

Devices it lists

DeviceProduct codeClassRoleSource
Ankle Arthroplasty Implantation SystemOYK2Manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Kidney Perfusion KitPIN2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Manufactureraccessdata.fda.gov
Prosthesis, Toe, Hemi-, PhalangealKWD2Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Software For Diagnosis/TreatmentOSN2Repackager or relabeleraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 17, 2026K260900DYNEX® External Fixation SystemsKTTSubstantially EquivalentVilex, LLCaccessdata.fda.gov
March 5, 2025K250304TITANEX Screw SystemsHWCSubstantially EquivalentVilex, LLCaccessdata.fda.gov
December 2, 2024K240475Hintermann Series H2 Total Ankle SystemHSNSubstantially EquivalentVilex, LLCaccessdata.fda.gov
August 1, 2024K240035TACTIX Vector Syndesmosis SystemHTNSubstantially EquivalentVilex, LLCaccessdata.fda.gov
January 30, 2024K231343Redemption Duo Hindfoot Nail SystemHSBSubstantially EquivalentVilex, LLCaccessdata.fda.gov
September 11, 2023K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemHWCSubstantially EquivalentVilex, LLCaccessdata.fda.gov
August 11, 2023K231493NITINEX Memory Compression StapleJDRSubstantially EquivalentVilex, LLCaccessdata.fda.gov
July 17, 2023K230462OPTIX H2 Patient Specific Instrument SystemHSNSubstantially EquivalentVilex, LLCaccessdata.fda.gov
April 25, 2023K230204ALPHALOK Plating SystemHRSSubstantially EquivalentVilex, LLCaccessdata.fda.gov
December 13, 2022K221342REDEMPTION Beaming SystemHWCSubstantially EquivalentVilex, LLCaccessdata.fda.gov
November 15, 2022K221558ALPHALOK Plating SystemHRSSubstantially EquivalentVilex, LLCaccessdata.fda.gov
September 11, 2020K202143Dynex MicroKTTSubstantially EquivalentVilex, LLCaccessdata.fda.gov
August 24, 2020K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemKTTSubstantially EquivalentVilex, LLCaccessdata.fda.gov
July 29, 2019K191289Bone Screw Line AdditionHWCSubstantially EquivalentVilex IN Tennessee, Inc.accessdata.fda.gov
November 7, 2017K171004Hintermann Series H2 Total Ankle SystemHSNSubstantially EquivalentDt Medtech, LLCaccessdata.fda.gov
March 24, 2016K151881X-Fix Line AdditionsKTTSubstantially EquivalentVilex IN Tennessee, Inc.accessdata.fda.gov
October 29, 2015K151456Small Bone Nail ImplantHSBSubstantially EquivalentVilex IN Tennessee, Inc.accessdata.fda.gov
September 10, 2014K141937TRIDENT FUSION IMPLANTHWCSubstantially EquivalentVilex IN Tennessee, Inc.accessdata.fda.gov
July 23, 2014K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESJDWSubstantially EquivalentVilex, Inc.accessdata.fda.gov
October 9, 2012K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)JDRSubstantially EquivalentVilex, Inc.accessdata.fda.gov
November 14, 2011K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILHSBSubstantially EquivalentVilex, Inc.accessdata.fda.gov
July 20, 2011K102401HEMI IMPLANT; MINI HEMI IMPLANTKWDSubstantially EquivalentVilex, Inc.accessdata.fda.gov
March 28, 2007K070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONKWDSubstantially EquivalentVilex, Inc.accessdata.fda.gov
November 22, 2005K052196VILEX X-FIXKTTSubstantially EquivalentVilex, Inc.accessdata.fda.gov
August 5, 2004K041289TALUS OF VILEX (TOV)HWCSubstantially EquivalentVilex, Inc.accessdata.fda.gov
August 5, 2004K041287VILEX BONE PLATE SYSTEMHWCSubstantially EquivalentVilex, Inc.accessdata.fda.gov
March 1, 2004K023684CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365KWDSubstantially EquivalentVilex, Inc.accessdata.fda.gov
March 18, 2002K014154VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00HWCSubstantially EquivalentVilex, Inc.accessdata.fda.gov
April 26, 1999K991197VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24HWCSubstantially EquivalentVilex, Inc.accessdata.fda.gov
April 26, 1999K991151VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREWHWCSubstantially EquivalentVilex, Inc.accessdata.fda.gov
January 16, 1998K973309VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREWHWCSubstantially Equivalent for Some IndicationsVilex, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 22, 201571344Class IITerminatedVilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Incidence of breakage is higher than expected.accessdata.fda.gov

Compare with other makers

Updated April 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.