Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251771

    Validate with FDA (Live)

    Date Cleared
    2025-12-16

    (189 days)

    Product Code
    Regulation Number
    888.3520
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Signature Orthopaedics' Cambridge Partial Knee is designed for a single compartment replacement of the natural knee joint. The Cambridge Partial Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

    Device Description

    The Cambridge Partial Knee is a unicompartmental knee system consisting of a femoral component and tibial component (meniscal insert overmoulded onto the tibial baseplate). The femoral and tibial components are intended for use with bone cement. The implant is for fixed partial knee replacement. Each size tibial implant has two variants, right lateral/left medial (RLLM) and right medial/left lateral (RMLL) condyle.

    The femoral component is a spherical, symmetrically designed prosthesis manufactured from cast cobalt chrome (CoCrMo). The meniscal bearing and tibial baseplate are a monobloc fixed tibial bearing consisting of a titanium (Ti6Al4V) baseplate overmoulded with UHMWPE GUR1020-E. The meniscal bearing is moulded over the tibial baseplate and machined to the correct size and geometry.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1