(91 days)
The Solitude™ Unipolar femoral head is intended for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Treatment of fractures that are unmanageable using other forms of therapy.
Solitude™ Unipolar Head
This document is a 510(k) premarket notification approval letter for a medical device called Solitude™ Unipolar Head. It is not a study document and therefore does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies.
The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on this input document.
§ 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.