§ 888.3041 Absorbable metallic bone fixation fastener.

(a) Identification. An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after osteosynthesis is achieved. (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 the anticipated conditions of use. The absorption profile must be characterized to completion (full absorption). The difficulty of any revision surgeries must be documented. (2) Non-clinical performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Testing must: (i) Evaluate the complete degradation profile of the device; (ii) Evaluate the initial mechanical performance; and (iii) Evaluate the mechanical performance as the device degrades. (3) The device must be demonstrated to be biocompatible. (4) The device must be demonstrated to be non-pyrogenic. (5) Performance data must demonstrate the sterility of the device. (6) Performance data must support the labeled shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality (i.e., degradation profile and mechanical performance) over the established shelf life. (7) Labeling must include: (i) Material composition; (ii) Absorption byproducts; (iii) A detailed summary of the product's technical parameters; (iv) An expiration date/shelf life; (v) Instructions for revision surgery; (vi) Time to complete absorption; and (vii) A summary of clinical data with the device.