(92 days)
Triathlon® Hinge Knee System:
Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s):
- · There is destruction of the joint surfaces, with or without significant bone deformity.
- · The cruciate and/or collateral ligaments do not stabilize the knee joint.
- · The ligaments are inadequate and/or the musculature is weak. And/or
- · Revision is required of a failed prosthesis where has been gross instability, with or without bone loss or inadequate soft tissue.
- · And/or where segmental resection and replacement of the distal femur is required.
Triathlon® Revision Insert X3®:
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. Additional Indications for 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.
- · Severe instability of the knee secondary to compromised collateral ligament integrity or function.
The previously cleared Triathlon® Hinge Knee (THK) System (K223528) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of Modular Rotating Hinge (MRH) bushings and MRH axle (K222056, K002552, K994207). A bumper locks this assembly. This assembly provides motion through the MRH axle/bushing combination in the flexion/extension plane. The articulation between bearing surfaces on the underside of a tibial bearing component and a hinge tibial insert provide motion in the rotating plane. A hinge tibial insert is assembled to a revision tibial baseplate which incorporates a longitudinal bore to accept a Triathlon® tibial sleeve or an MRH tibial sleeve. Optional distal femoral and tibial augments are available to fill bone defect. The Instructions for Use and package labels for the THK components are being updated to bear the MR Conditional symbol and MR Conditional parameters.
The subject Triathlon® Bushing and Axle (Standard Assembly Pack) contains sterile, singleuse devices that are being added to the previously cleared THK System (K223528) as an alternate option to MRH bushings and MRH axle to connect a stemmed femoral component and a stemmed tibial bearing component and provide motion through the flexion/extension plane.
This premarket notification also introduces the subject Triathlon® Revision Insert X3®, which is a sterile, single-use device that is intended for use in a total knee arthroplasty with the previously cleared Triathlon® Revision Tibial Baseplate (K223528) and Triathlon® TS Femoral Component (K172326, K141056, K070095) as part of the Triathlon® Total Knee System. The subject insert is available in seven sizes, and each size is available in seven different thicknesses. The subject insert is packaged together with Cobalt-Chrome (CoCr) stabilizer pin and filler bushing subcomponents that are assembled intraoperatively. The subject insert is assembled to the previously cleared Triathlon® Revision Baseplate (K223528), which incorporates a longitudinal bore to accept the filler bushing subcomponent. The stabilizer pin is inserted through the subject Triathlon® Revision Insert X3® and extends into filler bushing assembled within the Triathlon® Revision Tibial Baseplate to provide additional stability in the insert post.
This FDA K-number document (K230416) is for a medical device, specifically orthopaedic implants (knee systems), and thus does not involve acceptance criteria or studies related to AI/ML device performance. The document only lists pre-clinical (non-clinical) testing performed on the device components, such as materials characterization, wear analysis, fatigue testing, and biocompatibility, to demonstrate substantial equivalence to predicate devices. There is no mention of an algorithm or AI model, nor any associated acceptance criteria, study designs, or ground truth establishment relevant to AI/ML performance.
Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on the provided document. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence."
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.