(96 days)
The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented is designed for cemented 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 arthrosis, traumatic arthritis, rheumatoid 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, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
The Quadra-P implants are line extensions to the currently cleared Quadra-P implants (K181254).
The Quadra-P implants in this submission are comprised of the following products:
- Quadra-P STD (Stem size 00); .
- Quadra-P Short Neck (STD Stem sizes 0 10 and LAT Stem sizes 0 10); ●
- . Quadra-P Collared (STD Stem sizes 00 - 10 and LAT Stem sizes 0 - 10); and
- Quadra-P Cemented (STD Stem sizes 0 8 and LAT Stem sizes 0 8). ●
The Quadra-P implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads, and acetabular components.
The Quadra-P, Quadra-P short neck, and Quadra-P Collared are cementless stems manufactured from Titanium-Niobium alloy with a Titanium plasma spray coating (MectaGrip) on the proximal area and HA coating on the shaft. The Quadra-P Cemented stems manufactured from high nitrogen stainless steel.
The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120521 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115). or MectaCer Biolox Option Heads (K131518).
MectaCer Biolox Option Heads (K131518) cannot be combined with Quadra-P cemented stems, but only with the Quadra-P cementless stems.
The provided text is related to a 510(k) submission for a medical device (Quadra-P hip prosthesis) and does not contain information about software or AI-powered devices. Therefore, it does not include the type of acceptance criteria and study details you've requested regarding AI performance.
The document discusses the substantial equivalence of modifications to an existing hip prosthesis to predicate devices, focusing on mechanical testing and biocompatibility assessments. It explicitly states: "No clinical studies were conducted."
To clarify, the information you've requested (acceptance criteria, sample size for test/training set, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type) is typically found in submissions for AI/ML-powered medical devices, specifically for evaluating their diagnostic or prognostic performance. This document concerns a physical implantable device.
§ 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.