(104 days)
The Corin Adaptor Sleeve is indicated for use with a Corin Unipolar Modular Head and a Howmedica Osteonics femoral hip stem with a V40™ trunnion in partial hip replacement procedures for patients suffering from pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
The Corin Adapter Sleeve is a tapered sleeve component with a female V40™ taper to provide locking with a Howmedica Osteonics' femoral stem with a V40™ taper. In addition, the sleeve has a tapered male exterior surface that provides locking with a Corin Unipolar Modular Head. The Corin Adapter Sleeve is fabricated from Ti-6AI-4V alloy per ASTM F-136.
The provided document is a 510(k) summary for the Corin Adaptor Sleeve. It states that the device is substantially equivalent to legally marketed predicate devices in regards to intended use, design, materials, and operational principles. This type of submission (510k) usually relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with detailed acceptance criteria and performance data.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for a new device requiring efficacy studies. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.
The document primarily focuses on:
- Device Description: The Corin Adaptor Sleeve is a tapered component designed to connect a Corin Unipolar Modular Head to a Howmedica Osteonics femoral hip stem with a V40™ taper. It is made from Ti-6AI-4V alloy.
- Indications for Use: For partial hip replacement in patients with certain conditions (osteoarthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture) where the femoral head is affected, the acetabular cavity is normal, and acetabular replacement is not needed or desired.
- Substantial Equivalence: The device is considered substantially equivalent to existing predicate devices like the V40™/C-Taper Adaptor Sleeve and the Unitrax Unipolar System.
In summary, the 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on presenting new performance studies against specific acceptance criteria.
{0}------------------------------------------------
11071471 (pg 1/2)
510(k) Summary of Safety and Effectiveness
SEP 1 0 2007
| Proprietary Name: | Corin Adaptor Sleeve |
|---|---|
| Common Name: | Adaptor Sleeve |
| Classification Name and Reference: | 21 CFR §888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis. |
| Proposed Regulatory Class: | Class II |
| Product Codes: | KWL: prosthesis, hip, hemi-, femoral, metal |
| For Information contact: | Karen Ariemma,Senior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5718 Fax: (201) 831-6038 |
| Date Prepared: | May 4, 2007 |
Description:
The Corin Adapter Sleeve is a tapered sleeve component with a female V40™ taper to provide locking with a Howmedica Osteonics' femoral stem with a V40™ taper. In addition, the sleeve has a tapered male exterior surface that provides locking with a Corin Unipolar Modular Head. The Corin Adapter Sleeve is fabricated from Ti-6AI-4V alloy per ASTM F-136.
{1}------------------------------------------------
K071471 (pg 2/2)
Indications:
The Corin Adaptor Sleeve is indicated for use with a Corin Unipolar Modular Head and a Howmedica Osteonics femoral hip stem with a V40™ trunnion in partial hip replacement procedures for patients suffering from pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
Substantial Equivalence:
The Corin Adaptor Sleeve is substantially equivalent to other commercially available adaptor sleeves in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: the V40™/C-Taper Adaptor Sleeve and the Unitrax Unipolar System.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three abstract shapes that could be interpreted as profiles or intertwined forms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 0 2007
Howmedica Osteonics Corp % Ms. Karen Ariemma Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
Re: K071471 Trade/Device Name: Corin Adaptor Sleeve Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prothesis Regulatory Class: Class II Product Code: KWL Dated: August 29, 2007 Received: August 30, 2007
Dear Ms. Ariemma:
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. Karen Ariemma
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 vours.
Koubare Budur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
(1) Number (if known): _ צו מרי (1) 1 (1)
Device Name: Corin Adaptor Sleeve
Indications for Use:
The Corin Adaptor Sleeve is indicated for use with a Corin Unipolar Modular Head and a Howmedica Osteonics femoral hip stem with a V40™ trunnion in partial hip replacement procedures for patients suffering from pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laubare Buch
Division of Ger estorative and Neurological Devices
Page 1 of 1
57000 K071471
N/A