(90 days)
The Foundation® Porous Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed: : and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used in a cementless mode.
The Foundation® Porous Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) beads.
The Foundation® Porous Hip Stem is available with and without a calcar collar and has a Morse type taper to receive modular heads.
The provided document is a 510(k) submission for a medical device (Foundation® Porous Hip Stem) to the FDA. It does not contain any information regarding acceptance criteria, device performance measures, or study details typically found in a clinical or performance evaluation for an AI/ML medical device.
The document focuses on:
- Device Description: Materials, porous coating, availability with/without calcar collar, and modular heads.
- Intended Use: Specific conditions for total hip arthroplasty (degenerative joint disease, rheumatoid arthritis, correction of deformity, revision procedures, fractures).
- Comparable Features to Predicate Devices: Geometry, material, and indications are the same.
- Test Results (mentioned briefly): "fatigue testing on the Morse type taper." This is a mechanical engineering test, not a study involving human subjects or AI performance.
- FDA Correspondence: Substantial equivalence determination, regulatory class, and general compliance information.
Therefore, I cannot provide the requested information based on the given text. The questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set information are not applicable to the content of this 510(k) submission. This document pertains to a traditional orthopedic implant, not an AI-powered device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.