(77 days)
Not Found
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 hip prosthesis, which is a medical implant used to treat damaged hip joints caused by disease or injury, falling under the definition of a therapeutic device.
No
The device described is a hip prosthesis, which is an implant used to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a forged Co-Cr-Mo stem, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Endurance Calcar Hip Prosthesis is a physical implant (a hip stem) designed to be surgically placed within the human body to replace a damaged hip joint.
- Intended Use: The intended use is for surgical implantation in total hip arthroplasty, not for testing biological samples.
The information provided clearly describes a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Endurance Calcar Hip Prosthesis is indicated for cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty. The stem is especially suited to primary or revision cases where the calcar of the femur may be deficient and for cases of intertrochanteric fracture.
Product codes
87 JDI
Device Description
The Endurance Calcar Hip Prosthesis is a forged Co-Cr-Mo stem, available in one size and two stem lengths. The design of the stem is similar to the design of the size 3 DePuy Cemented Hip Stem (now called the Endurance hip stem) except that the Endurance Calcar has an offset that is midway between the standard and high offset Endurance stems, does not have a collar and does have a 2.25cm calcar platform which is used to seat the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral
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)
DePuy Cemented Hip Stem (tradenamed the Endurance Hip Stem), DePuy AML Calcar Hip Prosthesis
Reference Device(s)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUL : .
11 1 2 1996
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|----------------------------------------------------------------------------------|
| 510(K) CONTACT: | Cheryl Hastings
Manager, Pre-clinical Device Evaluation |
| TRADE NAME: | Endurance Calcar Hip Prosthesis |
| CLASSIFICATION: | Hip prosthesis semi-constrained,
metal/polymer, cemented (21 CFR
888.3350) |
| DEVICE PRODUCT CODE: | 87 JDI |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy Cemented Hip Stem
(tradenamed the Endurance Hip Stem) |
DePuy AML Calcar Hip Prosthesis
DEVICE DESCRIPTION AND INTENDED USE:
The Endurance Calcar Hip Prosthesis is a forged Co-Cr-Mo stem, available in one size and two stem lengths. The design of the stem is similar to the design of the size 3 DePuy Cemented Hip Stem (now called the Endurance hip stem) except that the Endurance Calcar has an offset that is midway between the standard and high offset Endurance stems, does not have a collar and does have a 2.25cm calcar platform which is used to seat the implant.
The Endurance Calcar Hip Prosthesis is indicated for cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty. The stem is especially suited to primary or revision cases where the calcar of the femur may be deficient and for cases of intertrochanteric fracture.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Endurance Calcar Hip Stem is similar to the Endurance Hip Stem in that they have the same basic design, are manufactured from the same material and are both intended for use in cemented total hip arthroplasty. The Endurance Calcar Hip Stem is similar to the AML Calcar Hip Stem in that both stems have calcar platforms, are intended for use in cemented total hip arthroplasty, and can be used in cases where the calcar of the femur is deficient.