(230 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a hip implant component. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven functionality.
Yes
The device is intended to treat specific medical conditions (osteoarthritis, inflammatory arthritis, etc.) and aid in relieving hip pain and restoring hip motion, which are therapeutic actions.
No
The text indicates that the device is a "Press-fit Flared Shell" intended for "treatment of patients who are candidates for total hip arthroplasty." Its purpose is to "aid the surgeon in relieving the patient of hip pain and restoring hip motion," which are therapeutic rather than diagnostic functions.
No
The device description clearly details a physical implant (metal shell and poly liners) intended for surgical implantation, not a software-only product.
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 for the treatment of patients undergoing total hip arthroplasty to relieve pain and restore motion. This is a surgical implant, not a diagnostic test.
- Device Description: The description details a metal shell and poly liners, which are components of a hip implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The Press-fit Flared Shell 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 metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is textured to provide a roughened surface for enhanced pressfit fixation.
The metal shell is hemispherical in shape and is available with. The screw holes are for the use of 6.5 mm cancellous bone screws for secondary 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
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
Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
OCT 1 1996
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: Press-fit Flared Shell
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained press-fit prosthesis per 21 CFR 888.3350
Description: The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is textured to provide a roughened surface for enhanced pressfit fixation.
The metal shell is hemispherical in shape and is available with. The screw holes are for the use of 6.5 mm cancellous bone screws for secondary 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 Press-fit Flared Shell 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 textured to provide a roughened surface for enhanced press-fit fixation. The Encore Press-fit Flared Shell flares at the rim to enhance the press fit, with a straight line rather than a change in radius .
Test Results: Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.