(25 days)
The use of the Implex Hip System is indicated for: a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis, b) Secondary revision of a previously unsuccessful femoral component or total hip replacement, c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results, d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved, e) Non-union or femoral neck or head fractures, f) Salvage of a failed primary or secondary total or hemi hip.
The Trabecular Metal Monoblock Acetabular Cup is manufactured from Trabecular Metal (Hedrocel Porous Tantalum), titanium alloy (Ti-6Al-4V), and direct compression molded ultra-high molecular weight polyethylene (UHMWPE). It is available with an ID of 28 mm, an OD range of 48 - 70 mm in 2 mm increments, and possesses a hybrid 0 - 10-degree face angle. The device utilizes the same instrumentation and surgical protocol as the Hedrocel and Trabecular Metal Monoblock Cups (K964509 and K003181). These acetabular devices are intended for use with Zimmer and Implex Components as described in K003181.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a medical device (The Trabecular Metal Monoblock Acetabular Cup), which details its description, indications for use, and a letter from the FDA determining substantial equivalence to predicate devices. It does not contain any performance data, clinical study results, or 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.