FDA.reportPublic FDA data

Wireforms

Primary DI
00842188128240
Brand
Wireforms
Company
Trimed, INC.
Model
VBP42-1
Catalog number
VBP42-1
Device description
Volar Buttress Pin, 42mm, 1-Hole
Published
2025-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDLPIN, FIXATION, SMOOTH, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDLPin, Fixation, Smooth, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243569000TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);TriMed, Inc.2025-01-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188128240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188128240008421881282408421881282400842188128240

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188132452Tools - TWFNSF-CADDY-LIDNSF-CADDY-LID2026-08-18
00842188127014Tools - FMSFMS-TRAY-LIDFMS-TRAY-LID2023-04-19
00842188100437Foot PlatesSP20-3SSP20-3S2016-09-07
00842188100444Foot PlatesSP20-3MSP20-3M2016-09-07
00842188100451Foot PlatesSP20-4SP20-42016-09-07
00842188100468Foot PlatesSP20-6SP20-62016-09-07
00842188100475Foot PlatesTP20-5TP20-52016-09-07
00842188100482Foot PlatesTP20-7TP20-72016-09-07
00842188100888Locking PlatesBRGPBRGP2016-09-07
00842188100949Hook PlatesMHOOK-5MHOOK-52016-09-07
00842188100956Hook PlatesMHOOK-7MHOOK-72016-09-07
00842188101526Osteotomy Compression PlatesUOCPUOCP2016-09-07
00842188101533Osteotomy Compression PlatesUOCP-SUOCP-S2016-09-07
00842188105425FPS Locking Screw 2.0mmCLS2.0-06CLS2.0-062016-09-07
00842188105432FPS Locking Screw 2.0mmCLS2.0-08CLS2.0-082016-09-07
00842188105449FPS Locking Screw 2.0mmCLS2.0-10CLS2.0-102016-09-07
00842188105456FPS Locking Screw 2.0mmCLS2.0-12CLS2.0-122016-09-07
00842188105463FPS Locking Screw 2.0mmCLS2.0-14CLS2.0-142016-09-07
00842188105470FPS Locking Screw 2.0mmCLS2.0-16CLS2.0-162016-09-07
00842188105487FPS Locking Screw 2.0mmCLS2.0-18CLS2.0-182016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132575SledsTrimed, INC.NDL2026-07-24
00842188132582SledsTrimed, INC.NDL2026-07-24
00842188131158SledsTrimed, INC.NDL2026-02-19
00842188131165SledsTrimed, INC.NDL2026-02-19
00842188129759K-wiresTrimed, INC.NDL2025-04-23
00842188128233WireformsTrimed, INC.NDL2025-02-12
00842188128257WireformsTrimed, INC.NDL2025-02-12
00842188128264WireformsTrimed, INC.NDL2025-02-12
00842188128271WireformsTrimed, INC.NDL2025-02-12
00842188128288WireformsTrimed, INC.NDL2025-02-12
00842188128295WireformsTrimed, INC.NDL2025-02-12
00842188129735WireformsTrimed, INC.NDL2025-02-12
00842188125348WireformsTrimed, INC.NDL2023-01-05
00842188125355WireformsTrimed, INC.NDL2023-01-05
00842188119859Generic InstrumentsTrimed, INC.NDL2019-07-26
00842188109041SledsTrimed, INC.NDL2016-09-07
00842188109058SledsTrimed, INC.NDL2016-09-07
00842188109065SledsTrimed, INC.NDL2016-09-07
00842188109072SledsTrimed, INC.NDL2016-09-07
00842188109089SledsTrimed, INC.NDL2016-09-07
00842188109096SledsTrimed, INC.NDL2016-09-07
00842188109102WireformsTrimed, INC.NDL2016-09-07
00842188109119WireformsTrimed, INC.NDL2016-09-07
00842188109126WireformsTrimed, INC.NDL2016-09-07
00842188109133WireformsTrimed, INC.NDL2016-09-07
00842188109140WireformsTrimed, INC.NDL2016-09-07
00842188109157WireformsTrimed, INC.NDL2016-09-07
00842188109164WireformsTrimed, INC.NDL2016-09-07
00842188109171WireformsTrimed, INC.NDL2016-09-07
00842188109188WireformsTrimed, INC.NDL2016-09-07