510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Vilex LLC

Mcminnville, TN, US

Vilex LLC appears in FDA device records in Mcminnville, TN. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
3
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Vilex LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Vilex IN Tennessee, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 27 510(k) clearances for Vilex LLC between 2011 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vilex LLC, by decision year
YearClearances
20112
20121
20141
20152
20161
20171
20192
20202
20211
20223
20234
20245
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260900DYNEX® External Fixation SystemsKTTSubstantially Equivalent
K250304TITANEX Screw SystemsHWCSubstantially Equivalent
K240475Hintermann Series H2 Total Ankle SystemHSNSubstantially Equivalent
K243408TACTIX Vector Syndesmosis SystemHTNSubstantially Equivalent
K233816REDEMPTION Charcot Plating SystemHRSSubstantially Equivalent
K240035TACTIX Vector Syndesmosis SystemHTNSubstantially Equivalent
K231343Redemption Duo Hindfoot Nail SystemHSBSubstantially Equivalent
K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemHWCSubstantially Equivalent
K231493NITINEX Memory Compression StapleJDRSubstantially Equivalent
K230462OPTIX H2 Patient Specific Instrument SystemHSNSubstantially Equivalent
K230204ALPHALOK Plating SystemHRSSubstantially Equivalent
K221342REDEMPTION Beaming SystemHWCSubstantially Equivalent
K221558ALPHALOK Plating SystemHRSSubstantially Equivalent
K212348ALPHALOK™ Plating SystemHRSSubstantially Equivalent
K212552Correx SoftwareKTTSubstantially Equivalent
K202143Dynex MicroKTTSubstantially Equivalent
K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemKTTSubstantially Equivalent
K191289Bone Screw Line AdditionHWCSubstantially Equivalent
K190543Cannulated Hemi ImplantKWDSubstantially Equivalent
K163487Ultima HA Coated Half Pins and WireJDWSubstantially Equivalent
K151881X-Fix Line AdditionsKTTSubstantially Equivalent
K150211EzFuze Implant SystemHWCSubstantially Equivalent
K151456Small Bone Nail ImplantHSBSubstantially Equivalent
K141937TRIDENT FUSION IMPLANTHWCSubstantially Equivalent
K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)JDRSubstantially Equivalent
K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILHSBSubstantially Equivalent
K102401HEMI IMPLANT; MINI HEMI IMPLANTKWDSubstantially Equivalent

Registered establishments

FDA registered establishments for Vilex LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10515261051526Vilex LLC111 MOFFITT ST, MCMINNVILLE, TN 37110 US2026and 21 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1723-2015Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Incidence of breakage is higher than expected.Class IITerminated
Z-1722-2015Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.Incidence of breakage is higher than expected.Class IITerminated
Z-1721-2015Vilex, 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain