(89 days)
The RC Buttress is intended for use to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder. The RC Buttress prevents the suture from pulling through the bone bridge between adjacent suture holes.
The RC Buttress is made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue.
The provided text is a 510(k) summary for the RC Buttress device, which is intended to protect sutures during rotator cuff repair. This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Description: The RC Buttress is made of LactoSorb®, a bioresorbable and biocompatible polymer.
- Intended Use: To protect the suture during transosseous bone tunneling in rotator cuff repair, preventing suture pull-through.
- Regulatory Information: It includes the submitter's details, product code, device name, and the FDA's 510(k) clearance letter (K991009) confirming substantial equivalence to a predicate device. This clearance is based on the device's indications for use and general controls provisions of the Act.
Therefore, I cannot provide the requested information, as it is not present in the provided text. The submission is a regulatory clearance document, not a detailed study report with performance metrics.
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510 (k) Summary of Safety and Effectiveness
Submitter: Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Tracy Bickel
Product Code: MAI
Device Name: RC Buttress
The RC Buttress is intended for use to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder. The RC Buttress prevents the suture from pulling through the bone bridge between adjacent suture holes.
The RC Buttress is made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 1999
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K991009 RC Buttress Trade Name: Regulatory Class: II Product Code: MAI March 24, 1999 Dated: Received: March 26, 1999
Dear Ms. Bickel:
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 controls provisions The general controls provisions of the Act 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Ms. Tracy Bickel
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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) NUMBER (IF KNOWN): | K991009 |
|---|---|
| DEVICE NAME: | RC Buttrees |
INDICATIONS FOR USE:
The RC Buttress is intended for use to protect the suture during its use in
ter. The RC Buttress is intended for use to proved the mail to be and the shoulder.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
"labels": [
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.