FDA.reportPublic FDA data

Cambridge Partial Knee Tibial Component, RLLM - AA,8

Primary DI
09348215145705
Brand
Cambridge Partial Knee Tibial Component, RLLM - AA,8
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
121-26-1018
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251771000Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.2025-12-16HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215145705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215145705093482151457059348215145705

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00885556779989VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVHSX2018-10-17
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19