(146 days)
The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Global Taper (GT) Tapered Hip System consists of hip stems and femoral heads with a new taper. The hip stem components of the GT Tapered Hip System are made of metal alloys. The devices are for single use. Cementless or cement fixation is available with these devices. The components of the Tapered Hip System have the same function as other hip systems designed for cemented and cementless fixation.
This document, K963509, is a 510(k) summary for the Smith & Nephew Orthopaedics Global Taper Tapered Hip System. It provides information about the device, its indications for use, and a general statement about its performance.
However, the provided text does not contain any information regarding specific acceptance criteria for device performance, nor details of a study (clinical or otherwise) that would "prove" the device meets these criteria.
Therefore, I cannot fulfill your request for the detailed table and study information. The document explicitly states: "Analysis results were acceptable and the components of the Tapered Hip System should perform as well as other hip systems." This is a general statement of equivalency, not a presentation of specific study results against performance metrics.
To answer your questions, I would need a different type of document, such as a clinical study report, a detailed performance testing report, or a marketing submission that includes more specific efficacy or safety data.
§ 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.