STERLING INTERFERENCE SCREW ST

K050767 · Regeneration Technologies, Inc. · HWC · Jun 9, 2005 · Orthopedic

Device Facts

• Record ID: K050767
• Device Name: STERLING INTERFERENCE SCREW ST
• Applicant: Regeneration Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

STERLING® Interference Screw ST is a bone fixation fastener used in orthopedic surgery. Device is machined from processed bovine cortical bone; features threaded design, internal hex-drive, and rounded proximal head. Available in lengths 15-40mm and diameters 7-10mm. Used by trained medical professionals in arthroscopic or open ACL/PCL reconstruction procedures to secure soft tissue grafts within femoral or tibial tunnels. Device provides mechanical fixation of the graft to bone during the healing process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, function, and material characteristics.

Technological Characteristics

Constructed of processed bovine cortical bone. Threaded design with internal hex-drive and rounded proximal head. Dimensions: 15-40mm length, 7-10mm diameter. Mechanical fixation device.

Indications for Use

Indicated for interference fixation in femoral and/or tibial tunnels during anterior cruciate ligament (ACL) reconstruction using soft tissue grafts, and fixation during posterior cruciate ligament (PCL) reconstruction using soft tissue grafts.

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

• Bioscrew Absorbable Interference Screw
• BioOss Anorganic Bovine Bone

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square on the left, followed by the word "Regeneration" in large, bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in smaller, thinner, black letters.

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA Tel [phone] Toil Free 877.343.683.3 Fax [phone] www.rtix.com

K050767 pge'41

## 510(K) Summary

Date: March 24, 2005

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

Proprietary Name: 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 ST is substantially equivalent to the Bioscrew Absorbable Interference Screw in design and function, and substantially equivalent to BioOss Anorganic Bovine Bone in materials.

## Description:

The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.

## Intended Use:

The STERLING® Interference Screw ST 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 ST and the BioScrew Absorbable Interference Screw have substantially equivalent design and function, but different materials. The STERLING® Interference Screw ST is constructed of bovine bone and is substantially equivalent in materials to another 510(k)-cleared product, BioOss Anorganic Bovine Bone.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUN 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carrie Hartill Regeneration Technologies Incorporated 11621 Research Circle Alachua, Florida 32615

Re: K050767

Trade/Device Name: STERLING® Interference Screw ST Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 24, 2005 Received: March 25, 2005

Dear Ms. Hartill:

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 prematted 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 11 Juan 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 Oiner general 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,

Hypt. Clude

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### CONFIDENTIAL

Regeneration Technologies, Inc. STERLING® Interference Screw ST 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known): K050767

Device Name:

STERLING® Interference Screw ST

Indications for Use:

The STERLING® Interference Screw ST is used to provide interference The STERENTO - and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

Prescription Use X (Part 21 CFR 801 Subpart D) 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

AND/OR

Over-The-Counter Use No
(21 CFR 801 Subpart C)
ON ANOTHER PAGE OF

NEEDED)

Kye Rhodes

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

510(k) Number K050767