(73 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint provide into subser patients where is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The Solution System® Hip Stem is indicated for comentless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.
The subject device, DePuy Solution System® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobaltchrome molybdenum alloy bead porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region. The stems are available in 10.5, 12.0 and 13.5 mm sizes.
The provided documentation is a 510(k) premarket notification for a medical device, specifically a hip prosthesis. These types of submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed analytical or clinical study data with specific acceptance criteria and performance metrics against those criteria.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation based on the provided document:
The submission focuses on establishing substantial equivalence to previously cleared devices (K030979, K953703, K013352) based on:
- Same intended use
- Indications for use
- Sterilization method
- Packaging
- Design
The FDA's decision letter (MAY 19, 2006) confirms their review of the Section 510(k) premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate devices, and therefore, a detailed clinical study with specific acceptance criteria as you've outlined is generally not required for this type of submission. Performance is implied to be equivalent to the predicate devices.
§ 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.