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510(k) Data Aggregation
(268 days)
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(60 days)
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot.
The HKT Anatomical Locking Trauma System is a collection of implantable bone plates and bone screws. The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot. This system consists of Bone Plates, Bone Screws and Washers
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(91 days)
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 stabilized by standard fracture-management techniques.
- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
The subject device is intended for primary or revision total knee arthroplasty.
The subject device is a sterile, single use device that is intended for use in primary or revision total knee arthroplasty with previously cleared Triathlon® femoral and tibial baseplate components. The subject device adds to the Triathlon® Total Knee System a tibial bearing insert option with an asymmetric articulating surface which is designed to increase medial conformity with the compatible femoral components. The design is intended to provide increased sagittal stability and allow for more natural rotational kinematics. This tibial bearing insert also introduces a material change to the locking wire subcomponent located on the anterior portion of the distal baseplate mating profile. The locking wire component is intended to assemble the insert with a compatible tibial baseplate. The locking wire provided with the Triathlon® X3® Medial Stabilized Tibial Bearing Insert is made from titanium alloy (Ti-6Al-4V).
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