(77 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head 3. or neck.
- Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
- Certain cases of ankylosis. র.
The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
The Summit DuoFix™ Porous Hip prosthesis is a collarless, titanium, tapered femoral stem. The hip stem is manufactured from titanium (Ti-6Al-4V) and has a sintered commercially pure bead porous coating (Porocoat®) titanium applied to the stem with a thin layer of hydroxyapatite (HA) coating applied. The hip stem consists of 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options.
The provided text is a 510(k) Summary for the DePuy Summit™ DuoFix™ Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this 510(k) summary.
Explanation:
- 510(k) Premarket Notification: This regulatory pathway is for medical devices that are "substantially equivalent" to a legally marketed predicate device. The primary goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to prove its performance against a predefined set of acceptance criteria in a new study.
- Focus on Substantial Equivalence: The document explicitly states: "The Summit™ DuoFix™ Hip Prosthesis has the same intended use, is made from similar materials and has the same basic design as the predicate devices and is therefore substantially equivalent." This is the core argument.
- "No performance standards have been established...": The document also notes under "Device Product Code" that "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems." This further emphasizes that there aren't FDA-mandated performance metrics that a study would be designed to meet.
To provide the requested details, one would typically need information from a full clinical trial report or a performance study that measures specific outcomes against predefined acceptance criteria, which is not part of this 510(k) submission.
§ 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.