(89 days)
Not Found
No
The description focuses on the mechanical design and materials of a hip implant, with no mention of AI or ML.
Yes
The device is described as reducing or relieving pain and/or improving hip function, which are therapeutic claims.
No
The device is a revision hip system intended for use in total hip arthroplasty to reduce pain and improve hip function. It is an implantable medical device, not a diagnostic tool that identifies conditions or analyzes data for diagnosis.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The PERFECTA® Revision Hip System is a surgical implant intended to be placed inside the body during a total hip arthroplasty. Its purpose is to replace a damaged hip joint and improve function, not to analyze samples taken from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples.
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
Not Found
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 plasma 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 the 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
skeletally mature patients
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
- Submitted abrasion testing demonstrates that the plasma spray porous coating is . comparable to sintered bead coating.
- . Submitted fatigue testing demonstrates that the PERFECTA® PS Revision Hip Stem was able to withstand test loading designed to simulate in vivo loading.
Key Metrics
Not Found
Predicate Device(s)
K962267, PERFECTA® Hip System and PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc., Integral Total Hip System manufactured by Biomet
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
9- 8-96 : 11:05AM :WRIGHT MED'CAL TECH .-
10 1996
Image /page/0/Picture/3 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the company name.
Contact Person: Date:
Cristie Manuel September 8, 1996
510(k) Summary
| Trade/Proprietary Name: | PERFECTA® PS Revision Hip Stem |
|---|---|
| 510(k) Number: | K962267 |
| Common Name: | Plasma Spray Coated Femoral Hip Stem |
| Classification: | Class II |
| Predicate Devices: | PERFECTA® Hip System and PERFECTA® Revision Hip |
| System manufactured by Wright Medical Technology, Inc. | |
| and Integral Total Hip System manufactured by Biomet |
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 plasma 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 the 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® PS Revision Hip Stem is substantially equivalent to the PERFECTA® Hip System and the PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc. and the Integral Total Hip System manufactured by Biomet.
Testing
- Submitted abrasion testing demonstrates that the plasma spray porous coating is . comparable to sintered bead coating.
- . Submitted fatigue testing demonstrates that the PERFECTA® PS Revision Hip Stem was able to withstand test loading designed to simulate in vivo loading.