(181 days)
No
The 510(k) summary describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthesis designed to replace parts of the hip, specifically the femoral component, which serves to alleviate pain and disability, thereby restoring function and improving the patient's condition.
No
The Delta Hip Prosthesis is an implant designed for hip replacement surgery, not for diagnosing medical conditions. Its purpose is to physically replace a damaged part of the hip.
No
The device description clearly states it is a "femoral stem manufactured from either Tivanium or Ti-6A1-7Nb alloy," which are physical materials, indicating it is a hardware device.
Based on the provided text, the Delta Hip Prosthesis is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. The text describes a surgical implant designed to be placed inside the human body to replace a damaged hip joint.
- The intended use and device description clearly indicate a surgical implant for orthopedic purposes. It's a physical prosthesis for hip replacement, not a diagnostic tool that analyzes biological samples.
Therefore, the Delta Hip Prosthesis falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for 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 fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Femoral head, Femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AuFranc-Turner Type Total Hip, Charnley Type Total Hip, and Müller Type . Total Hip, manufactured by Zimmer, preenactment devices, K901687, K873797, K850055
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
- 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
2
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