STERLING INTERFERENC SCREW HT

K052405 · Regeneration Technologies, Inc. · HWC · Nov 16, 2005 · Orthopedic

Device Facts

• Record ID: K052405
• Device Name: STERLING INTERFERENC SCREW HT
• Applicant: Regeneration Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.

Device Story

STERLING® Interference Screw HT is a bone fixation device machined from processed bovine cortical bone. It features a threaded design with an external squared-drive; lengths range from 20-35mm; diameters range from 7-12mm. Used by trained medical professionals in arthroscopic or open ACL/PCL reconstruction procedures to provide interference fixation for bone-tendon-bone grafts. The device is manufactured using the BioCleanse® process, which provides viral inactivation. It is intended to remodel comparably to allograft bone.

Clinical Evidence

No human clinical data provided. Evidence includes animal model studies demonstrating comparable remodeling to allograft and a viral inactivation study using the BioCleanse® process, which demonstrated a greater than six log reduction of a panel of viruses.

Technological Characteristics

Constructed from processed bovine cortical bone sourced from a closed U.S. herd. Threaded design with external squared-drive. Dimensions: 20-35mm length, 7-12mm diameter. Sterilized via BioCleanse® process.

Indications for Use

Indicated for interference fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction using bone-tendon-bone grafts. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• STERLING® Interference Screw ST

Submission Summary (Full Text)

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K052405 page 142

## NOV 1 6 2005

#### 510(K) Summary

Date: August 31, 2005

Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: [phone] x4382 Fax: [phone]

Proprietary Name: STERLING® Interference Screw HT

Common Name: Screw, fixation, bone

Classification: HWC, orthopedics panel

Code Section: 21 CFR 888.3040

Substantial Equivalence:

The STERLING® Interference Screw HT is equivalent to the STERLING® Interference Screw ST 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.

Intended Use:

The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.

### Summary of Technological Characteristics:

The STERLING® Interference Screw HT and the STERLING® Interference Screw ST have equivalent materials, design and function. The STERLING® Interference Screw HT is constructed of bovine bone and is equivalent in materials to another 510(k)-cleared product, the STERLING® Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Interference Screw HT is a closed herd located in the U.S.A.

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The STERLING® Interference Screw HT has been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worstory to
representation of the BioCleanse® process, used in the manifacture of STERLING® Interference Screw HT, has shown greater than a six log reduction of a panel of viruses to below detectable limits.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a river or stream. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Ms. Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, Florida 32615

> K052405 Trade/Device Name: Sterling® Interference Screw HT Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 31, 2005 Received: September 13, 2005

Dear Ms. Hartill:

Re:

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.

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Page 2 - Ms. Carrie Hartill

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

C.C. McMullen

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

_ 注

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Regeneration Technologies, Inc. STERLING® Interference Screw HT 510(k) Pre-market Notification

# Indications for Use

510(k) Number (if known): K052405

Device Name:

STERLING® Interference Screw HT

Indications for Use: The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.

Over-The-Counter Use No Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

KJS 2405

(Division Sign-Off) Division of General, Restorati e, and Neurological Devices

519(k) Number上のメイン