(199 days)
Not Found
Not Found
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip stem intended for total hip arthroplasty to treat conditions like osteoarthritis and avascular necrosis, which directly addresses and treats a medical condition.
No
The device is a hip stem intended for surgical implantation in patients undergoing total hip arthroplasty, not for diagnosing medical conditions.
No
The device description clearly details a physical implant (hip stem) made of Ti-6AI-4V with specific geometric features and surface treatments, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of patients undergoing total hip arthroplasty due to various conditions affecting the femoral head and neck. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the physical characteristics and materials of a hip stem, which is a prosthetic implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests.
Therefore, based on the provided information, the Foundation® Press-Fit Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. It is intended to be used press-fit.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The proximal body is trapezoidal in cross-sectional geometry. The distal stem portion is conical in shape and has flutes to provide rotational stability. A coronal slot in the larger stems decreases implant stiffness.
The stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°.
The Foundation® Press-Fit Hip Stem is fabricated from wrought/forged Ti-6AI-4V. The proximal body of the stem has a plasma sprayed surface to enhance press-fit fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Laboratory testing of the Morse type taper was conducted.
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.
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
ﺍﻟﻤﺴﺘﻮﻯ
Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Building 300 Austin, TX 78757 512-795-8696
MAY - 5 1997
Trade Name: Foundation® Press-Fit Hip Stem
Common Name: Press-fit hip stem
Classification Name: Hip joint metal/polymer semi-constrained prosthesis
Description: The proximal body is trapezoidal in cross-sectional geometry. The distal stem portion is conical in shape and has flutes to provide rotational stability. A coronal slot in the larger stems decreases implant stiffness.
The stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°.
The Foundation® Press-Fit Hip Stem is fabricated from wrought/forged Ti-6AI-4V. The proximal body of the stem has a plasma sprayed surface to enhance press-fit fixation.
Intended Use: The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. It is intended to be used press-fit.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include Ti-6Al-4V substrate, straight stem, symmetric, calcar collar, no collar, distal fluted stem, modular heads and distal coronal slot..
Test Results: Laboratory testing of the Morse type taper was conducted.