§ 888.3610 Medial knee implanted shock absorber.
(a)Identification. A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface to improve symptoms of osteoarthritis. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i)Evaluation of improvement of knee function and reduction of osteoarthritis s
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§ 888.3610 Medial knee implanted shock absorber.
(a) Identification. A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface to improve symptoms of osteoarthritis. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Evaluation of improvement of knee function and reduction of osteoarthritis symptoms, including pain and function; and
(ii) Evaluation of relevant adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Evaluation of the mechanical function and durability of the implant (including evaluation of absorber unloading capacity, fretting and corrosion, static strength, wear analysis, and fatigue testing); and
(ii) Evaluation of worst-case device range of motion.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life.
(7) A training program must be included so that upon completion of the training program, the user can safely and successfully implant the device.
(8) Labeling must include the following:
(i) Validated methods and instructions for reprocessing of any reusable components; and
(ii) A shelf life.
[91 FR 39009, June 29, 2026]