(80 days)
The UNI-ROM™ Total Hip Stem is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The UNI-ROM™ Femoral Hip Stem is a one-piece porous coated hip stem that manufactured from titanium alloy (Ti-6Al-4V). The stem is designed with steps on the outer surface of the porous-coated area to encourage compressive loading of the bone there by allowing for uncemented fixation. The proximal circumferential area is porous coated with commercially pure titanium. The UNI-ROM™ Femoral Hip Stem is anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The UNI-ROM™ Femoral hip stem can be used in either the right or left hip and mates with the femoral hip head using an 11/13 Morse-type taper. Further, the femoral stem is designed to accept an S-ROM Co-Cr Femoral head or an S-ROM Ceramic Femoral Head.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The document is a 510(k) summary for the UNI-ROM™ Femoral Hip Stem, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed devices (S-ROM Femoral Hip Stem and P.F.C. 2 Femoral Stem).
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria/Reported Device Performance: The document describes the physical characteristics, materials, and intended use of the UNI-ROM™ Femoral Hip Stem and compares it to predicate devices in a "Similarities and Differences Matrix." It states that "The determination of substantial equivalence for this device was based in part on bench top performance data," but it does not provide any specific acceptance criteria, benchmarks, or quantitative performance data from these bench tests.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As no performance study results are detailed, there is no information on sample sizes, data origins, expert involvement, adjudication methods, or separate standalone or MRMC studies. Ground truth establishment for any such studies is also not mentioned. The "bench top performance data" mentioned is not elaborated upon in a way that would allow for these details to be extracted.
In summary, the document establishes the substantial equivalence of the UNI-ROM™ Femoral Hip Stem largely based on design, materials, and intended use similarities to predicate devices, and alludes to some bench testing, but it does not provide the detailed performance study information requested.
§ 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.