(63 days)
Not Found
Not Found
No
The summary describes a physical implant (femoral resurfacing component) and its material and size options. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typical indicators of AI/ML technology in medical devices.
No
The device is a component for hip resurfacing surgery, which aims to relieve pain and improve hip function, but it is an implanted device, not a therapeutic device in the sense of delivering therapy or monitoring.
No
Explanation: The device is a femoral resurfacing component intended for surgical implantation to improve hip function and relieve pain in patients with non-inflammatory degenerative joint disease, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Femoral Resurfacing Component" manufactured from "Cobalt Chrome Alloy," indicating it is a physical implant, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the CONSERVE® Femoral Resurfacing Component is a surgical implant used to replace a portion of the hip joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.
Product codes
KXA
Device Description
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- Manufactured from Cobalt Chrome Alloy .
- 11 Sizes in 2mm increments .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orthomet Resurfacing Femoral Component
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS DEC - 1 2006
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the CONSERVE® Femoral Resurfacing Component.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | September 28, 2006 |
| Contact Person: | Theresa Leister |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | CONSERVE® Femoral Resurfacing Component |
| Common Name: | Hemi-resurfacing femoral component |
| Classification Name and Reference: | 21 CFR 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis – Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ KXA |
DEVICE INFORMATION
A. INTENDED USE
The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.
B. DEVICE DESCRIPTION
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- Manufactured from Cobalt Chrome Alloy .
- 11 Sizes in 2mm increments .
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and design of the CONSERVE® Femoral Resurfacing Component are identical to Orthomet Resurfacing Femoral Component. The materials of the CONSERVE® Femoral Resurfacing Component are substantially equivalent to those of the predicate device. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the CONSERVE® Femoral Resurfacing Component are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Ms. Theresa Leister Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
DEC - 1 2006
Re: K062960
Trade Name: CONSERVE® Femoral Resurfacing Component Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: Class II Product Code: KXA Dated: November 2, 2006 Received: November 3, 2006
Dear Ms. Leister:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Theresa Leister
This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: _CONSERVE® Femoral Resurfacing Component
Indications For Use:
The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with noninflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbere Brielm for Man
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K062960 ೆ 10(k) Number
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