(78 days)
The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following:
Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-Hip Replacement: Fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The Fiber Metal Taper Hip Prosthesis is a collarless, modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy. The modular connection of the femoral stem is a Morse-type 12/14 proximal neck taper designed to mate with the corresponding 12/14 bore of a femoral head component. The proximal body of the stem features a trapezoidal geometry. The Fiber Metal Taper Hip Prosthesis will be available in nine sizes (10 through 18) with size increments of 1 mm. Stem sizes 12 through 16 mm are designed with two proximal body options, standard and large metaphysis. A commercially pure titanium circumferential fiber metal pad is metallurgically bonded to the proximal one-third of the stem. The surface of the midstem region features a roughened surface providing for bone ongrowth and implant fixation. The distal shaft is tapered in both the medial/lateral plane and the anterior/posterior plane.
The provided text describes the Zimmer Biomet VerSys™ Hip System—Fiber Metal Taper Hip Prosthesis, a femoral hip prosthesis. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document is a "Summary of Safety and Effectiveness" which focuses on device description, intended use, and comparison to predicate devices, but lacks the specific clinical study data needed to answer the prompt thoroughly.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font. The logo is black and white.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness VerSys™ Hip System--Fiber Metal Taper Hip Prosthesis
FEB 1 3 1997
-
Submitted By: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131 -
. Contact Person:
Karen Cain Regulatory Affairs Specialist Telephone: 219-372-4219 Fax: 219-372-4605 -
. Date:
-
November 22, 1996 ....
-
Trade Name: VerSys™ Hip System--Fiber Metal Taper Hip Prosthesis .
-
Common Name: Femoral Hip Prosthesis .
-
Classification Name: Hip joint metal/polymer/metal semiconstrained porous coated . uncemented prosthesis
-
Predicate Devices for the Femoral Stem: .
Image /page/0/Picture/21 description: The image shows the logo for A Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a complex pattern of lines and shapes, while the company name is written in a serif font.
{1}------------------------------------------------
. Device Description
The Fiber Metal Taper Hip Prosthesis is a collarless, modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy. Tivanium Alloy is a high fatigue strength material with a long history of successful clinical use and exceptional biocompatibility. The Fiber Metal Taper Hip Prosthesis is primarily designed for use in patients with a champagne flute (trumpet) type femur but may be used in other patients based upon the surgeon's judgment.
The modular connection of the femoral stem is a Morse-type 12/14 proximal neck taper designed to mate with the corresponding 12/14 bore of a femoral head component. The neck of the prosthesis increments progressively in offset and length with increasing stem size. Progressive offsets and neck lengths are designed to provide restoration of natural joint geometry and kinematics.
The proximal body of the stem features a trapezoidal geometry which optimizes metaphyseal fill of the proximal femur and provides rotational stability. The Fiber Metal Taper Hip Prosthesis will be available in nine sizes (10 through 18) with size increments of 1 mm. Stem sizes 12 through 16 mm are designed with two proximal body options, standard and large metaphysis, to accommodate variations in patient anatomy.
A commercially pure titanium circumferential fiber metal pad is metallurgically bonded to the proximal one-third of the stem. The purpose of the fiber metal pad is to achieve biological fixation to bone without the use of bone cement. The surface of the midstem region features a roughened surface providing for bone ongrowth and implant fixation. The distal shaft is tapered in both the medial/lateral plane and the anterior/posterior plane to encourage proximal fixation and minimize distal stem engagement in the canal.
-
Intended Use .
The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following: -
Total Hip Replacement: -
Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip
{2}------------------------------------------------
dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
-
Hemi-Hip Replacement:
Fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. -
Comparison to Predicate Devices .
All hip systems listed above are substantially equivalent to each other and the Fiber Metal Taper Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. All predicate devices feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultra-high molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemi-hip acetabular component. All predicate devices and the Fiber Metal Taper Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.
Clinical Data .
One current method of hip prosthesis implantation relies upon mechanical fixation through initial implant stabilization with secondary fixation supplied by bone ingrowth or bone ongrowth. The Fiber Metal Taper Hip Prosthesis is an example of a device designed to achieve biologic fixation to bone through bone ingrowth and bone ongrowth. Many studies published in the literature report satisfactory results are obtained through the use of porous coated, cementless hip prostheses.
RA11601K.510
§ 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.