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510(k) Data Aggregation
K Number
K230078Device Name
TRAX® CR Total Knee System
Manufacturer
Date Cleared
2023-11-03
(297 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Amplitude
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRAX® CR Total Knee System is indicated for use:
- In primary total knee arthroplasty (TKA) as a result of:
- · Painful, disabling joint disease of the knee resulting from degenerative arthritis, 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.
- In revision of previous osteotomy,
- In revision of previous unsuccessful unicompartimental or femoro-patellar knee.
The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement only.
Device Description
The TRAX® CR Total Knee System belongs to the category of Cruciate Retaining (CR) total knee prostheses (only anterior-cruciate is sacrificed).
The TRAX® CR Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral component, a tibial implant and a patellar component. The tibial implant consists of two components: bearing insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
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K Number
K161414Device Name
Anatomic Total Knee System
Manufacturer
Date Cleared
2017-01-19
(241 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
AMPLITUDE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, 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.
The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.
Device Description
The ANATOMIC® Total Knee System belongs to the category of sliding posterior-stabilized total knee prostheses (PS, posterior-cruciate substituting).
The ANATOMIC® Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral implant, a tibial implant and a patellar implant. The tibial implant consists of two components: tibial insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The femoral implant comes in right and left versions and in various sizes. The tibial baseplate and tibial insert are symmetrical and can be used both for right and left sides. The tibial baseplate comes in various sizes. The tibial insert is available in various sizes and thicknesses.
The nominal size of the insert includes the thickness of the tibial baseplate. The standard keel (supplied in the tibial baseplate packaging) must be mounted and blocked on the implant by the surgeon before implantation.
The components are for cemented used only.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
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