(30 days)
The indications for use of the Unitrax® C-Taper Neck Adjustment Sleeve, in keeping with those of the legally marketed predicate devices, are as follows: For Use as a Hemi-Hip Replacement: - Femoral head/neck fractures or non-unions. - Aseptic necrosis of the femoral head/neck - Osteo- and post traumatic arthritis
This Special 510(k) submission is intended to address a design modification to the predicate Unitrax® V40™ Neck Adjustment Sleeve. The Unitrax® V40™ Neck Adjustment Sleeve is a tapered sleeve component whose outer diameter mates with the bore of the Unitrax® Unipolar Head, and inner diameter mates with the trunnion neck of the femoral stem. The design modification involves changing the inner taper diameter of the current sleeve component. The modified device will allow Unitrax® Unipolar Heads to be compatible with Osteonics C-Taper femoral stems. The modified component, the Unitrax® C-Taper Neck Adjustment Sleeve, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. The Unitrax® C-Taper Neck Adjustment Sleeves are manufactured from wrought cobaltchromium alloy, which conforms to ASTM F-1537. The intended use of the subject Unitrax® C-Taper Neck Adjustment Sleeve is identical to that of the Unitrax® V40™ Neck Adjustment Sleeve.
This is a medical device, not an AI/ML device, therefore, the requested information is not applicable.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.