FDA.reportPublic FDA data

TITANEX

Primary DI
00841731142894
Brand
TITANEX
Company
VILEX LLC
Model
AZ-WG25
Device description
TITANEX ARTEMIS Parallel Wire Guide, 25 deg
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231504000TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC2023-09-11HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731142894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731142894008417311428948417311428940841731142894

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731131690REDEMPTION Beaming SystemRFT65-40T-24RFT65-40T-242024-03-08
00841731131706REDEMPTION Beaming SystemRFT65-45T-24RFT65-45T-242024-03-08
00841731131713REDEMPTION Beaming SystemRFT65-50T-24RFT65-50T-242024-03-08
00841731131720REDEMPTION Beaming SystemRFT65-55T-24RFT65-55T-242024-03-08
00841731131737REDEMPTION Beaming SystemRFT65-60T-24RFT65-60T-242024-03-08
00841731131744REDEMPTION Beaming SystemRFT65-65T-24RFT65-65T-242024-03-08
00841731131751REDEMPTION Beaming SystemRFT65-70T-24RFT65-70T-242024-03-08
00841731131768REDEMPTION Beaming SystemRFT65-75T-24RFT65-75T-242024-03-08
00841731131775REDEMPTION Beaming SystemRFT65-80T-24RFT65-80T-242024-03-08
00841731131782REDEMPTION Beaming SystemRFT65-85T-24RFT65-85T-242024-03-08
00841731131799REDEMPTION Beaming SystemRFT65-90T-24RFT65-90T-242024-03-08
00841731131805REDEMPTION Beaming SystemRFT65-95T-24RFT65-95T-242024-03-08
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
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M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
00810055525164NON NAVIGATED STYLET-OBTURATOR ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525188CANNULATED PROBE IMPACTION CAP ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525195CANNULATED PROBE HANDLE ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525218GRANITE CANNULATED PROBE SHAFTSi-Bone Inc.LXH2026-10-27
00889024702233OsseoFitZimmer, Inc.LXH2026-10-27
00889024702240OsseoFitZimmer, Inc.LXH2026-10-27
00889024702479OsseoFitZimmer, Inc.LXH2026-10-27
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23