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510(k) Data Aggregation

    K Number
    K190402
    Device Name
    Triathlon Total Knee System-Additional Components
    Manufacturer
    Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
    Date Cleared
    2019-08-22

    (184 days)

    Product Code
    JWH, MBH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stryker Orthopaedics (aka Howmedica Osteonics Corp.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. - · Post-traumatic loss of knee joint configuration and function. - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - · Revision of previous unsuccessful knee replacement or other procedure. - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Per-Apatite components are intended for uncemented use only. The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or non-functioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: · Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - Severe degeneration or trauma requiring extensive resection and replacement - · Femoral and Tibial bone voids - · Metaphyseal reconstruction The Triathlon TS Cone Augments are intended for cemented or cementless use.
    Device Description
    The additional components being added to the Triathlon Total Knee System are: - Size 0 Cruciate Retaining Femoral Component (cemented use) . - o Size 0 Primary Cemented Tibial Baseplate - Size 0 Tritanium Tibial Baseplate for cemented/cementless use ● - Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ● - New PS Femoral Component with modified intercondylar PS box (cemented use) ● - o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.
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