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(a) Identification. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Post-operative evaluation of knee pain and function; and
(ii) Durability as assessed by re-tear or re-operation rate.
(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Device performance characteristics, including resorption and ligament healing at repair site; and
(ii) Adverse effects as assessed by gross necropsy and histopathology.
(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Characterization of materials, including chemical composition, resorption profile, and mechanical properties; and
(ii) Simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation, and user interface.
(4) The device must be demonstrated to be biocompatible.
(5) Performance data must demonstrate the device to be sterile and non-pyrogenic.
(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) Labeling must include the following:
(i) Identification of device materials and specifications;
(ii) A summary of the clinical performance testing conducted with the device;
(iii) Instructions for use, including compatibility with other ACL repair instrumentation or devices;
(iv) Warnings regarding post-operative rehabilitation requirements; and
(v) A shelf life.
[87 FR 80041, Dec. 29, 2022]
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