STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES

K051615 · Regeneration Technologies, Inc. · MQV · Aug 15, 2005 · Orthopedic

Device Facts

• Record ID: K051615
• Device Name: STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES
• Applicant: Regeneration Technologies, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Device Story

STERLING Cancellous Chips and Cubes are bovine bone-derived bone void fillers. Processed via BioCleanse Tissue Sterilization Process; provided in 1-10mm sizes. Intended for surgical implantation into non-structural bony voids or gaps in extremities, spine, ilium, or pelvis. Acts as a scaffold that remodels into the recipient's skeletal system. Used by surgeons in clinical settings to fill defects resulting from surgery or trauma.

Clinical Evidence

No human clinical data provided. Evidence consists of animal model studies demonstrating comparable remodeling to allograft and a viral inactivation study using a worst-case BioCleanse process representation, showing >6 log reduction of a viral panel.

Technological Characteristics

Bovine bone-derived bone void filler; processed via BioCleanse Tissue Sterilization Process. Provided in 1-10mm sizes. Remodels into host bone. Non-mechanical, non-electronic.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, ilium, pelvis) not intrinsic to structural stability. Applicable to surgically created or traumatic osseous defects.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• PolyGraft™ BGS

Reference Devices

• STERLING® Interference Screw ST

Submission Summary (Full Text)

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Tel [phone] Toll Free 877.343.683 Fax [phone] www.rtix.com

# AUG 1 5 2005

## 510(K) Summary

K051615 Date: August 5, 2005

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

Proprictary Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes

Common Name: Filler, bone void, calcium compound

Classification: MQV, Orthopedics Panel

Code Section: 21 CFR 888.3045

#### Substantial Equivalence:

STERLING" Cancellous Chips and STERLING" Cancellous Cubes are substantially equivalent to PolyGrafi™ BGS in design and function, and are composed of bovine bone processed in the same manner as the STERLING* Interference Screw ST.

#### Description:

STERLING® Cancellous Chips and STERLING* Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.

#### Intended Use:

STERLING* Cancellous Chips and STERLING* Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created

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osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

### Summary of Technological Characteristics:

STERLING® Cancellous Chips, STERLING® Cancellous Cubes, and PolyGraft™ BGS have substantially equivalent design and function, but are composed of different materials. The STERLING® Cancellous Chips and STERLING* Cancellous Cubes are constructed of bovine bone processed in the same manner as the STERLING* Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes is a closed herd located in the U.S.A.

STERLING® Cancellous Chips and STERLING* Cancellous Cubes have been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process, used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes, has shown a greater than six log reduction of a panel of viruses.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

AUG 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051615

Trade/Device Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 5, 2005 Received: August 8, 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 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 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,

Mark A. Milken

Mark 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): STERLING® Cancellous Chips Device Name: STERLING® Cancellous Cubes Indications for Use: STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Prescription Use Over-The-Counter 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)

Mark A. Millman

.

ivision Sign-Off) Triston of General, Restorative Id Neurological