(79 days)
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Not Found
No
The summary describes a metallic hip resurfacing prosthesis and its material specifications. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is intended for the "relief of pain and disability, and restoration of hip function" within patients, which are therapeutic effects. It also mentions addressing deformities and reinstating function following degenerative effects.
No
Explanation: The device is a prosthetic implant for hip resurfacing, intended to restore hip function and relieve pain. It replaces a portion of the femoral head and is not used for diagnosis.
No
The device description clearly states it is a metallic resurfacing prosthesis made from Cobalt Chromium Molybdenum alloy, which is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Metallic Resurfacing Prostheses" intended for use within the hip joint to replace a portion of the femoral head. It is a surgical implant.
- Intended Use: The intended use is to relieve pain, restore function, and address deformities of the hip joint through surgical implantation.
There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis. The device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
This prosthesis is also intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as previously failed femoral osteotomy, previous fracture, or early deformities of the proximal end of the femur. These make it anatomically impossible to use a conventional femoral component. As above the acetabulum should be essentially normal.
Product codes
KXA
Device Description
These devices are intended for use with hip joints in which the concentricity of the bearing surface, and supportive bone structure of the acetabulum, is essentially normal.
Selection of the implant from the available range of sizes provides reasonably precise articulation.
The devices are used to resurface the head of the femur, and so reinstate function of the hip joint following the degenerative effects of osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses consists of 5 sizes ranging from 40 to 56mm diameter in 4mm increments.
These devices are intended for use with bone cement and have been designed to replace only a small portion of the of the worn femoral head. Stable and immobile fixation of the implant provides stress bearing contact at the bone / prosthetic interface.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured from Cobalt Chromium Molybdenum alloy in accordance with ISO 5832-4/BS 7252/4 : 1997 - 'Specification for cobalt-chromium-molybdenum casting alloy', and is cast in accordance with BS 7254 Pt.5 1990- Specification for production of castings made of cobalt-chromium-molybdenum alloy'.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured in accordance with BS EN 12010 : 1998 - 'Non-active Surgical Implants - Joint Replacement Implants -Particular Requirements', BS EN ISO 14630:1998 - General requirements for non-active surgical implants and BS EN 12563:1999 Non active surgical implants - Joint replacements - Specific requirements for hip joint replacement implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
femoral head, acetabulum, hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510(k) SUMMARY
Corin Medical Name of Company: The Corinium Centre Cirencester Gloucestershire GL7 1YJ England
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses. Name of Device:
Device Description:
These devices are intended for use with hip joints in which the concentricity of the bearing surface, and supportive bone structure of the acetabulum, is essentially normal.
Selection of the implant from the available range of sizes provides reasonably precise articulation.
The devices are used to resurface the head of the femur, and so reinstate function of the hip joint following the degenerative effects of osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses consists of 5 sizes ranging from 40 to 56mm diameter in 4mm increments.
These devices are intended for use with bone cement and have been designed to replace only a small portion of the of the worn femoral head. Stable and immobile fixation of the implant provides stress bearing contact at the bone / prosthetic interface.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured from Cobalt Chromium Molybdenum alloy in accordance with ISO 5832-4/BS 7252/4 : 1997 - 'Specification for cobalt-chromium-molybdenum casting alloy', and is cast in accordance with BS 7254 Pt.5 1990- Specification for production of castings made of cobalt-chromium-molybdenum alloy'.
The Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses are manufactured in accordance with BS EN 12010 : 1998 - 'Non-active Surgical Implants - Joint Replacement Implants -Particular Requirements', BS EN ISO 14630:1998 - General requirements for non-active surgical implants and BS EN 12563:1999 Non active surgical implants - Joint replacements - Specific requirements for hip joint replacement implants.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Public Health Service
FEB 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive Suite 190 Tampa, Florida 33612
Re: K994153
Trade Name: Cormet 2000 Hemi Hip Metallic Resurfacing Prostheses Regulatory Class: II Product Code: KXA Dated: December 8, 1999 Received: December 8, 1999
Dear Mr. Corrance:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Mr. Craig Corrance
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Sage
Gr James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ( of /
510(k) Number (if known):_ K 994153
Device Name: Comet 2000 Hemi Hip Resurfacing Prosthesis
Indications For Use:
Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
This prosthesis is also intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as previously failed femoral osteotomy, previous fracture, or early deformities of the proximal end of the femur. These make it anatomically impossible to use a conventional femoral component. As above the acetabulum should be essentially normal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell Payne
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K999153
Prescription Use (Per 21 CFR 801. OR
Over-The-Counter Use //
(Optional Format 1-2-96)