(181 days)
The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component 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 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 Delta Hip Prosthesis is a collarless, modular femoral stem manufactured from either Tivanium or Ti-6A1-7Nb alloy both of which are high-fatigue strength materials with a history of successful clinical use and exceptional biocompatibility. Delta Hip stem sizes 9 through 15, 17 and 19 will be available in either material.
The Delta Hip Prosthesis is designed for primary hip replacement in patients with a champagne flute type femur. The trapezoidal geometry provides for maximum metaphyseal fill of the proximal femur and apposition to cortical bone. Rotational stability is enhanced by the wedge fit of the stem in the proximal femur.
The modular connection of the femoral stem is a Morse-type 12/14 neck taper designed to mate with the corresponding 12/14 bore of a femoral head component.
The provided text is a "Summary of Safety and Effectiveness" for the Delta Hip Prosthesis, a medical device submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/software-as-a-medical-device (SaMD) submission.
Instead, this document describes a traditional medical device (a hip prosthesis) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. The "studies" mentioned are literature reports of successful clinical use of similar devices, not a specific performance study for the Delta Hip Prosthesis with defined acceptance criteria.
Thus, I cannot fulfill the request as the information is not present in the provided text. The document is for a hardware medical device from 1996, and the questions posed are geared towards software/AI-based medical devices or clinical trials with specific endpoints, which are not applicable here.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in lowercase letters.
OCT -8 1996 K9613
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Delta Hip Prosthesis
-
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:
April 9, 1996 -
. Trade Name:
Delta Hip Prosthesis -
. Common Name:
Femoral Hip Prosthesis -
. Classification Name:
Hip joint metal/polymer semiconstrained uncemented prosthesis -
. Predicate Devices for the Femoral Stem:
- AuFranc-Turner Type Total Hip, Charnley Type Total Hip, and Müller Type . Total Hip, manufactured by Zimmer, preenactment devices
- F-24 Femoral Hip Prosthesis, manufactured by Astel, K901687, cleared -September 7, 1990
- TI-FITTM Total Hip System, manufactured by Smith & Nephew Richards, K873797, cleared November 2, 1987
Image /page/0/Picture/21 description: The image contains a number that appears to be '170'. The number is written in a bold, sans-serif font. The digits are clearly visible and well-defined against the background.
Image /page/0/Picture/22 description: The image shows a geometric design with a hexagonal outer shape. Inside the hexagon, there is a complex arrangement of lines and smaller triangular shapes. The design appears symmetrical and intricate, with a central point from which the lines and triangles radiate outwards.
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- Profile™ Total Hip System, manufactured by DePuy, K850055, cleared April 23, 1985
- CLS Total Hip Replacement System (Protek, Inc.), distributed by Intermedics Orthopedics, Inc.
- Device Description .
The Delta Hip Prosthesis is a collarless, modular femoral stem manufactured from either Tivanium or Ti-6A1-7Nb alloy both of which are high-fatigue strength materials with a history of successful clinical use and exceptional biocompatibility. Delta Hip stem sizes 9 through 15, 17 and 19 will be available in either material.
The Delta Hip Prosthesis is designed for primary hip replacement in patients with a champagne flute type femur. The trapezoidal geometry provides for maximum metaphyseal fill of the proximal femur and apposition to cortical bone. Rotational stability is enhanced by the wedge fit of the stem in the proximal femur.
The modular connection of the femoral stem is a Morse-type 12/14 neck taper designed to mate with the corresponding 12/14 bore of a femoral head component.
- Intended Use ●
The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component 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 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
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fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
- Comparison to Predicate Devices .
The Delta Hip Prosthesis is substantially equivalent to all hip systems listed above 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 are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.
Clinical and Nonclinical Data .
A current method of hip prosthesis implantation relies on mechanical fixation through initial implant stabilization with secondary fixation supplied by bone ongrowth. The Delta Hip Prosthesis is an example of a device designed to achieve biologic fixation to bone without the use of bone cement.
Many studies published in the literature report satisfactory results with the use of hip prostheses that are substantially equivalent to the Delta Hip Prosthesis.
RA03602K.510
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.