(63 days)
The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc® UHMWPE liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
The TriFlange™ Acetabular Cup System is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
The patient specific TriFlange™ Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated Duraloc acetabular cup with three patient specific illial, ischial and pubic flanges added to reinforce weak acetabula similar to the Protrusio Cage. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges.
This document is a 510(k) summary for a medical device called the "TriFlange™ Acetabular Cup System." It describes a hip implant and its intended uses, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to other legally marketed devices, which is a regulatory pathway for medical devices in the US. It lists similar devices, describes the product, and states its intended use and indications for use. It also includes the FDA's letter of clearance.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, or details about training sets.
- Information about experts, ground truth establishment, or adjudication methods.
- Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
This document is purely for regulatory clearance and does not detail performance testing against specific acceptance criteria.
§ 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.