(83 days)
None
None
No
The description focuses on the materials and mechanical design of a hip implant, with no mention of AI/ML technologies or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended to treat patients suffering from various conditions affecting the hip, such as osteoarthritis and avascular necrosis, with the goal of relieving pain and restoring hip motion. These objectives align with the definition of a therapeutic device.
No
Explanation: The provided text describes an acetabular component for total hip arthroplasty, which is a prosthetic implant used in treatment. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly details physical components made of metal and polyethylene, indicating it is a hardware medical device, not software-only.
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 device is a metal backed acetabular component for total hip arthroplasty. This is a surgical implant used to replace a damaged hip joint.
- Device Description: The description details the materials and design of a physical implant (metal shell and polyethylene liners).
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum 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. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes
Not Found
Device Description
The hemispherical metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for press-fit enhanced fixation. The metal shell has three spikes to provide enhanced press-fit fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
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
surgeon
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
Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
DePuy 500 Series acetabular components
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
JAN 1 4 1997
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Suite 300 Austin, TX 78759 (512) 206-1437 Ashley M. Bock
Trade Name: Metal Acetabular Component
Common Name: Metal acetabular component
Classification Name: Hip joint metal/polymer semi-constrained press-fit prosthesis per 21 CFR 888.3350
Description: The hemispherical metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for press-fit enhanced fixation. The metal shell has three spikes to provide enhanced press-fit fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
Intended Use: The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum 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. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is plasma sprayed to provide a roughened surface for enhanced fixation. The spikes are comparable to the DePuy 500 Series acetabular components.
Test Results: Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.