(150 days)
Charnley-Type Total Hip Prosthesis, ZCH Hip Prosthesis, Longevity™ Monoblock Hip Prosthesis
Not Found
No
The description focuses on the material, design, and mechanical testing of a hip prosthesis, with no mention of AI or ML capabilities.
Yes
The device is a prosthesis intended to treat severe hip pain and disability, which aligns with the definition of a therapeutic device.
No
The document describes a hip prosthesis, which is an implant used in surgical procedures, not a device for diagnosing medical conditions.
No
The device description clearly states it is a "modular cemented femoral hip prosthesis manufactured from forged high-strength Zimaloy Alloy," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Heritage Hip prosthesis is for use in "cemented total and hemi-hip arthroplasty procedures." This describes a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The description details a physical implantable device made of Zimaloy Alloy, designed to replace parts of the hip joint.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Heritage Hip prosthesis does not perform this function. It is a therapeutic device implanted during surgery.
Therefore, the Heritage Hip prosthesis is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures.
The indications for total hip arthroplasty are:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity.
- Patients with acute femoral neck fractures.
The indications for hemi-hip arthroplasty are:
- 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 fractures in the aged.
- Nonunion of femoral neck fractures.
- Secondary avascular necrosis of the femoral head.
- Pathological fractures of the femoral neck.
- Osteoarthritis in which the femoral head is primarily affected.
Product codes
Not Found
Device Description
The Heritage Hip Prosthesis is a modular cemented femoral hip prosthesis manufactured from forged high-strength Zimaloy Alloy. The design of the stem includes a small proximal collar with flats included on the anterior and posterior sides of the stem The medial surface of the stem is designed with a semispherical radius. The stems also have a distal hole for use with an optional distal centralizer. The angle of the stem neck is 132 degrees for greater offset and increased range of motion. The stem is designed with a Morse taper for use with modular femoral heads. The outer surface of the stems are smoothly polished for cemented use. Five primary stem sizes are available and described as sizes one through five. Two stems, CDH and valgus, are available with slightly less offset neck lengths as needed. Three revision stems are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Fatigue testing was performed on the proximal section of two stem sizes and on the distal section of another stem. All stems survived at the specified load for 10,000,000 cycles. The testing demonstrated that the stems met the predetermined design criteria and that the stems can be expected to perform similarly to other stems tested to the same criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Charnley-Type Total Hip Prosthesis, ZCH Hip Prosthesis, Longevity™ Monoblock Hip Prosthesis
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with a large, stylized letter "Z" above the word "Zimmer." The letter "Z" is bold and black, with a distressed or textured appearance. The word "Zimmer" is written in a sans-serif font, also with a distressed texture, and is positioned directly below the "Z." The overall impression is of a vintage or worn design.
Image /page/0/Picture/1 description: The image shows the text "JAN - 9 1997". The text is black and appears to be printed on a white background. The text is slightly blurry, but still legible. The text is likely a date, with "JAN" representing January, "9" representing the day, and "1997" representing the year.
Summary of Safety and Effectiveness Heritage™ Hip Prosthesis System
K963109
Submitted by: .
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Prepared by: .
Lynnette Whitaker, RAC Manager Regulatory Affairs 219-372-4561
- Date: .
August 8, 1996
Trade Name: .
Heritage™ Hip Prosthesis System
Common Name: .
Femoral Hip Prosthesis
Classification Name: .
Hip Joint Metal/Polymer Semiconstrained Cemented Prosthesis, 21 CFR 888.3350
Predicate Devices: .
Charnley-Type Total Hip Prosthesis ZCH Hip Prosthesis Longevity™ Monoblock Hip Prosthesis
l
65
1
Device Description: .
The Heritage Hip Prosthesis is a modular cemented femoral hip prosthesis manufactured from forged high-strength Zimaloy Alloy. The design of the stem includes a small proximal collar with flats included on the anterior and posterior sides of the stem The medial surface of the stem is designed with a semispherical radius. The stems also have a distal hole for use with an optional distal centralizer. The angle of the stem neck is 132 degrees for greater offset and increased range of motion. The stem is designed with a Morse taper for use with modular femoral heads. The outer surface of the stems are smoothly polished for cemented use. Five primary stem sizes are available and described as sizes one through five. Two stems, CDH and valgus, are available with slightly less offset neck lengths as needed. Three revision stems are available.
Intended Use: ●
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures.
The indications for total hip arthroplasty are:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, l . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital 2. femoral epiphysis.
- Patients suffering from disability due to previous fusion. 3.
- Patients with previously failed endoprostheses and/or total hip components in 4. the affected extremity.
- Patients with acute femoral neck fractures. న్.
The indications for hemi-hip arthroplasty are:
-
- Fracture dislocation of the hip.
-
- Elderly, debilitated patients when a total hip replacement is contraindicated.
-
- Irreducible fractures in which adequate fixation cannot be obtained.
2
- Certain high subcapital fractures and comminuted femoral fractures in the aged. 4.
-
- Nonunion of femoral neck fractures.
- Secondary avascular necrosis of the femoral head. 6.
- Pathological fractures of the femoral neck. 7.
- Osteoarthritis in which the femoral head is primarily affected. 8.
Performance Data: .
Fatigue testing was performed on the proximal section of two stem sizes and on the distal section of another stem. All stems survived at the specified load for 10,000,000 cycles. The testing demonstrated that the stems met the predetermined design criteria and that the stems can be expected to perform similarly to other stems tested to the same criteria.
RA08601K.510
67