FDA.reportPublic FDA data

V2 TriVerse Femoral Cutting Block

Primary DI
09348215128326
Brand
V2 TriVerse Femoral Cutting Block
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
122-22-4367
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222380000TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.2022-10-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215128326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215128326093482151283269348215128326

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215199890Triple Taper Stem Standard Offset Collared Size 069-00112026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 069-00122026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 069-00212026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 069-00222026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 169-01112026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 169-01122026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 169-01212026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 169-01222026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 269-02112026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 269-02122026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 269-02212026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 269-02222026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 369-03112026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 369-03122026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 369-03212026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 369-03222026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 469-04112026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 469-04122026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 469-04212026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 469-04222026-09-22

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Primary DI, Brand, Company table
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