(259 days)
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dyplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
- Certain cases of ankylosis.
Conformity stem, cemented is for cemented use only.
The "United" Conformity stem, cemented is a triple tapered, polished, collarless stem. It is available in various sizes with standard and high offset types to accommodate various hip surgical requirements. Conformity stem, cemented is manufactured from Co-Cr-Mo alloy which conform to ASTM F799-11 (Raw material: ASTM F1537-11/ISO 5832-12:2007). It is intended to be fixed only with the use of PMMA bone cement and should be used with "United" Cement restrictor.
For total hip arthroplasty, Conformity stem, cemented can be used with "United"acetabular liner, cup and femoral head. For bipolar hip replacement, Conformity stem, cemented can be used with "United" bipolar prosthesis.
The provided text is a 510(k) summary for a medical device (Conformity stem, cemented) and does not describe a study involving an AI/algorithm. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical properties, FEM analysis, ROM simulation, bacterial endotoxin testing).
Therefore, I cannot provide information on acceptance criteria and study details related to an AI/algorithm according to your request. The document explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."
If this was a misunderstanding and you were looking for the acceptance criteria and performance of the hip stem itself, and not an AI or algorithm, please let me know.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.