(90 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical properties and clinical history, with no mention of AI or ML technologies.
Yes
The device is intended for the relief of pain and restoration of hip function due to various conditions, which are therapeutic goals.
No
The device description indicates it is an acetabular cup system used to resurface the acetabulum as part of a total hip replacement, which is a therapeutic intervention, not a diagnostic one. Its purpose is to restore function and relieve pain, not to diagnose a condition.
No
The device description clearly states it is an "Acetabular Cup System" and describes physical components made of cobalt chrome alloy and plasma spray coating, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Relief of pain and restoration of hip function" by replacing the acetabulum. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "Acetabular Cup System" used to "resurface the acetabulum" and is implanted into the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
This device is a surgical implant used in orthopedic surgery.
N/A
Intended Use / Indications for Use
Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and Netier of pain and restoration of mip state effects, avascular necrosis, and total hip revision.
The C-Fit and DC-Fit plasma sprayed acetabular components are intended for use QNLY with bone cement.
Product codes
JDI
Device Description
Acetabular Cup System for use with previously cleared femoral stems and modular heads.
The acetabular cups are available in a range of diameters and are plasma sprayed.
The devices are used to resurface the acetabulum and are used in combination with UHMWPE inserts, femoral stems and modular heads to reinstate function following the degenerative effects of osteo and rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.
The acetabular cups are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as a key for mechanical interlock with PMMA bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
This submission is supported by extensive mechanical test data confirming the devices' safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Mallory Head Acetabular Cup range
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
Image /page/0/Picture/0 description: The image shows the text "510(k) SUMMARY" in bold, underlined font. Above this text is a handwritten string of characters that appears to be "K972995". The handwriting is in black ink and is somewhat stylized.
NOV 10 1997
| Name of Company: | Corin Medical Ltd |
|---|---|
| The Corinium Centre | |
| Cirencester | |
| Gloucestershire | |
| GL7 1YJ | |
| England | |
| Name of Device: | C-Fit and DC-Fit Acetabular Cup System |
| Device Description: | Acetabular Cup System for use with previously cleared femoral stems |
| and modular heads. |
The acetabular cups are available in a range of diameters and are plasma sprayed.
The devices are used to resurface the acetabulum and are used in combination with UHMWPE inserts, femoral stems and modular heads to reinstate function following the degenerative effects of osteo and rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.
The acetabular cups are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as a key for mechanical interlock with PMMA bone cement.
Summary of substantial equivalence and safety and effectiveness
Corin claim that the range of C-Fit and DC-Fit Cups are substantially equivalent to the Mallory Head Acetabular Cup range which has been promoted in the USA by Biomet Inc since 1990. The reasons for this are summarised below.
- Both are modular cups manufactured from cobalt chrome alloy and utilise UHMWPE a) liners.
- b) Both are coated with a plasma spray of the same alloy.
- Both are designed for cemented use and for use with screws. c)
- Both are available in a range of sizes from 42mm 70mm and can accommodate a d) range of femoral head sizes.
This submission is supported by extensive mechanical test data confirming the devices' safety and effectiveness. The plasma coated C-Fit and DC-Fit Acetabular Cups have been in clinical use outside the USA for ten years and two years respectively and no significant postoperative problems have been reported.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NON 10 1997
Mr. Craiq Corrance ·President Corin U.S.A. 10500 University Center Drive, Suite 130 Tampa, Florida 33612
Re : K972995 The C-Fit and DC-Fit Acetabular Cup System Trade Name: Regulatory Class: II Product Code: JDI Dated: July 21, 1997 ¯ Received: August 12, 1997
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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Mr. Craig Corrance
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th
510(k) Number (if known)
The C-Fit & DC-Fit Acetabular Cup System______________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE
Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and Netier of pain and restoration of mip state effects, avascular necrosis, and total hip revision.
The C-Fit and DC-Fit plasma sprayed acetabular components are intended for use QNLY with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | X |
|---|---|
| (per 21 CFR 801.109) | |
| OR | |
| Over The-Counter Use | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K972995 |