(65 days)
Cemented and non-cemented total joint replacement in cases of:
- Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty
Each stem consists of two separate parts, a proximal metaphyseal segment and a distal stem. A variety of stem lengths and proximal segment sizes allow the surgeon to "construct" the proper sized implant while in surgery. All pieces are interchangeable. The device utilizes a modular femoral head taper fit on to the stem at the time of surgery. The proximal segment is designed to replace the proximal portion of the femur in cases of severe bone loss. The device is porous coated. The proximal components are available in 5 resection levels and 7 widths. A hole through the proximal component gives the surgeon the option of using a trochanter plate and trochanter bolt or a trochanter claw. This assembly will allow the greater trochanter to be compressed against the prosthesis for enhanced fixation and proximal stability. Distal stems are available in six lengths, 165mm, 200mm, 240mm, 250mm and 300mm. Stems are available with 40%, 80% or 100% of the stem porous coated, as well as a non-coated, splined configuration. Since the stems are modular, left and right components are not necessary. The proximal and distal segments are joined by means of a Morse locking taper similar to that used to attach the modular head components to most hip stems. Additional fixation is achieved through a locking screw inserted through the driving platform on the metaphyseal component and engaging with the stem taper.
The provided document is a 510(k) premarket notification for a medical device (Mallory-Head® Modular Calcar Femoral Component). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:
- Clinical Testing: None provided.
Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This type of submission relies on demonstrating substantial equivalence to predicates through non-clinical testing (engineering analysis, finite element analysis, and mechanical testing) rather than new clinical data.
In summary, as per the provided document:
There is no information available regarding:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.