(22 days)
The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.
The provided text is a 510(k) summary for the STERLING® Interference Screw HT and ST devices. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving device performance against such criteria. The studies mentioned are related to material characteristics and remodeling in an animal model, not clinical performance metrics typically associated with acceptance criteria for AI/ML-based devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the provided input does not contain this kind of data. The document describes a traditional medical device (bone fixation screw) and its regulatory submission, not a software or AI/ML device that would typically have acceptance criteria presented in the manner requested.
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510(K) Summary
Date: February 22, 2006
Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-418-3607
Proprietary Name: STERLING® Interference Screw HT STERLING® Interference Screw ST
Common Name: Screw, fixation, bone
Classification: HWC, orthopedics panel
Code Section: 21 CFR 888.3040
Substantial Equivalence:
The STERLING® Interference Screw HT and STERLING® Interference Screw ST are substantially equivalent to predicate devices in materials, design, and function.
Description:
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.
Intended Use:
The STERLING® Interference Screw ST is used to provide interference fixation of femoral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
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K066253 page-sq2
The STERLING® Interference Screw HT is used to provide interference fixation in The STERENTS Interent reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.
Summary of Technological Characteristics:
Summally of Technological Characew HT and the STERLING® Interference Screw ST have materials, design and function equivalent to predicate devices. The source S f have materials, accession and sufference of STERLING® Interference Screw HT and STERLING® Interference Screw ST is a closed herd located in the U.S.A. The STERLING® Interference Screw HT and STERLING® Interference Screw ST have been shown to remodel comparably to allograft in an animal model.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2006
Ms. Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615
Re: K060253
Trade/Device Name: Sterling® Interference Screw HT, Sterling® Interference Screw ST Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 1, 2006 Received: February 1, 2006
Dear Ms. Simpson:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa Simpson
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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Lewis
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: STERLING® Interference Screw HT STERLING® Interference Screw ST
Indications for Use:
The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.
Over-The-Counter Use No Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Herlin Lewin
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.