(a) Identification. A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In vivo performance testing under anticipated conditions of use must demonstrate:

(i) The device provides sufficient stability to allow for fracture healing; and

(ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must:

(i) Assess the stability of the device in a rescue screw scenario;

(ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware;

(iii) Demonstrate the device can withstand dynamic loading without device failure; and

(iv) Characterize wear particle generation.

(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 over the established shelf life.

(7) Labeling must include:

(i) A detailed summary of the device technical parameters;

(ii) Information describing all materials of the device;

(iii) Instructions for use, including device removal; and

(iv) A shelf life.

[87 FR 11294, Mar. 1, 2022]