(324 days)
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No
The description focuses on the material, design, and mechanical properties of a hip implant, with no mention of AI or ML.
Yes
The device is intended to reduce or relieve pain and improve hip function in patients undergoing total hip arthroplasty, which are therapeutic effects.
No
Explanation: The device is a monolithic design femoral component intended for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a monolithic design femoral component manufactured from titanium alloy, indicating it is a physical implant, not software.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The PERFECTA® Revision Hip System is a surgical implant designed to be placed inside the body during a hip replacement surgery. It is a physical component, not a tool for analyzing biological samples.
- Intended Use: The intended use is to "be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function." This describes a surgical procedure and its outcome, not a diagnostic test performed on a sample.
The information provided clearly describes a medical device used in vivo (within the body) for surgical treatment, not in vitro (in glass, referring to laboratory testing).
N/A
Intended Use / Indications for Use
The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Product codes
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Device Description
The PERFECTA® Revision Hip System is a monolithic design femoral component. The device is manufactured from titanium alloy (ASTM F-136) with a titanium alloy wire arc spray coating. The stem is available in two configurations: straight and bowed. All configurations have a calcar platform, from 2.0cm to 3.75cm. All sizes, except for 12mm x 190mm, have a coronal slot. The stem is designed to be press-fit or can be used with bone cement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The PERFECTA® Revision Hip System demonstrates acceptable fatigue strength. In addition the titanium wire arc spray coating demonstrates less weight loss as compared to the sintered bead control specimen through a comparable range of loads.
Key Metrics
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Predicate Device(s)
PERFECTA® Hip System by Orthomet, a division of Wright Medical Technology, Inc., Osteonics® Arc Depositioned Femoral Components
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows a stylized letter "W" logo. The "W" is formed by three triangles, with the top two triangles slightly overlapping the bottom triangle. The logo is black and is set against a white background. A registered trademark symbol is located at the bottom right of the logo.
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The word "WRIGHT" is in large, bold, sans-serif font at the top. Below that, in a smaller font, is the text "MEDICAL TECHNOLOGY, INC." There is a line separating the company name from the address below.
OCT 24 1996
Contact Person: Date:
Cliff Kline September 13, 1995
K T S S S S
510(k) SUMMARY
Trade/Proprietary Name: Common Name: Classification: Predicate Device:
PERFECTA® Revision Hip System Wire Spray Coated Femoral Hip Stem Class II PERFECTA® Hip System by Orthomet, a division of Wright Medical Technology, Inc. and the Osteonics® Arc Depositioned Femoral Components
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The PERFECTA® Revision Hip System is a monolithic design femoral component. The device is manufactured from titanium alloy (ASTM F-136) with a titanium alloy wire arc spray coating. The stem is available in two configurations: straight and bowed. All configurations have a calcar platform, from 2.0cm to 3.75cm. All sizes, except for 12mm x 190mm, have a coronal slot. The stem is designed to be press-fit or can be used with bone cement.
The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Substantial Equivalence
The PERFECTA® Revision Hip System is substantially equivalent to the PERFECTA® Hip System by Orthomet, a division of Wright Medical Technology, Inc. and the Osteonics® Arc Depositioned Femoral Components
Testing
The PERFECTA® Revision Hip System demonstrates acceptable fatigue strength. In addition the titanium wire arc spray coating demonstrates less weight loss as compared to the sintered bead control specimen through a comparable range of loads.