(88 days)
No
The 510(k) summary describes a mechanical implant (femoral resurfacing component) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The description focuses on the material, size, and surface treatment of the device.
Yes
The device is indicated for "reduction or relief of pain and/or improved hip function," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device, CONSERVE® Pressfit Femoral Resurfacing Component, is a surgical implant designed to treat non-inflammatory degenerative joint disease, not to diagnose a condition.
No
The device description clearly indicates it is a physical implantable component made of Cobalt Chrome Alloy, 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, or tissue) to provide information about a person's health.
- Device Description: The CONSERVE® Pressfit Femoral Resurfacing Component is a physical implant made of Cobalt Chrome Alloy, designed to be surgically placed in the hip joint.
- Intended Use: Its purpose is to replace or resurface a part of the femur to reduce pain and improve hip function. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, the CONSERVE® Pressfit Femoral Resurfacing Component is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CONSERVE® Pressfit 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.
CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use
Product codes
KXA
Device Description
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- . Manufactured from Cobalt Chrome Alloy
- 12 Sizes in 2mm increments .
- . Plasma Spray undersurface
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
CONSERVE® Cemented Femoral Component (K062960), Biomet Pressfit Head Resurfacing Device (K023188)
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.
0
Image /page/0/Picture/1 description: The image shows handwritten text. The text includes the date "2008" and the characters "p. 1/2". The handwriting is in black ink and appears to be on a white background. The text is slightly blurry, suggesting it may be a scan or a photograph of a document.
DEC 1 2 2008
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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® Pressfit Femoral Resurfacing Component.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | September 12, 2008 |
| Contact Person: | Theresa Leister |
| Senior Regulatory Affairs Specialist | |
| Proprietary Name: | CONSERVE® Pressfit Femoral Resurfacing |
| Component | |
| Common Name: | Femoral Resurfacing 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® Pressfit 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® Pressfit Femoral Resurfacing Component is intended for non-cemented use
B. DEVICE DESCRIPTION
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- . Manufactured from Cobalt Chrome Alloy
- 12 Sizes in 2mm increments .
- . Plasma Spray undersurface
1
082673
p.2/2
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use, design, and material of the CONSERVE® Pressfit Femoral Resurfacing Component are substantially equivalent to the CONSERVE® Cemented Femoral Component (K062960) and the Biomet Pressfit Head Resurfacing Device (K023188). The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the CONSERVE® Pressfit Femoral Resurfacing Component are adequately supported by the substantial equivalence information and materials information provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
DEC 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Ms. Theresa Leister Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K082673
Trade/Device Name: CONSERVE® Pressfit Femoral Resurfacing Component Regulation Number: 21 CFR 888. 3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: September 12, 2008 Received: September 15, 2008
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 adulteration.
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.
3
Page 2 - Ms. Theresa Leister
This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
0 8 2 6 7 3
Indications for Use
510(k) Number (if known):
Device Name: _CONSERVE® Pressfit Femoral Resurfacing Component
Indications For Use:
The CONSERVE® Pressfit 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.
CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use
Prescription Use × (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)
Mark A. Millman
(Division Sign.Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082673
1 of 1