(299 days)
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.
- · Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The M-Vizion Femoral Revision System is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.
The proximal body is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is a straight stem made of titanium alloy and the principal feature consists of shard fins that potentially increase the rotation stability. The locking screw is made of titanium alloy and coated with TiNbN.
This is a 510(k) summary for the Medacta M-Vizion Femoral Revision System Extension, which is a medical device and not an AI/ML product. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable to this document.
The document discusses the substantial equivalence of the new device extensions to previously cleared predicate devices based on non-clinical performance data (engineering rationale and mechanical testing) to ensure safety and effectiveness. No clinical studies were conducted as the new sizes were determined not to represent a new worst-case scenario.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.