OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

K091321 · Bacterin International, Inc. · MQV · Sep 11, 2009 · Orthopedic

Device Facts

• Record ID: K091321
• Device Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Applicant: Bacterin International, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoSelect™ DBM Putty is indicated for use as a bone void filler for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of the bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

Device Story

OsteoSelect™ Demineralized Bone Matrix (DBM) Putty is a bone void filler composed of processed human bone demineralized and combined with an absorbable carrier (carboxymethylcellulose and phosphate buffered saline). The putty-like consistency allows for easy surgical application to fill voids or gaps in the extremities and pelvis that are not intrinsic to bony stability. The device is osteoconductive and possesses osteoinductive potential. It is intended to be absorbed by the body within 90 days. The device is used by surgeons in clinical settings to treat osseous defects from surgery or trauma.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing, biocompatibility testing, and in vivo osteoinductive potential testing using an athymic rat model. Processing methods were validated for viral inactivation potential against a panel of model human viruses.

Technological Characteristics

Material: Processed human demineralized bone matrix (DBM) with carboxymethylcellulose and phosphate buffered saline carrier. Form factor: Putty. Properties: Osteoconductive, osteoinductive, biodegradable, absorbable within 90 days. Sterilization: Not specified.

Indications for Use

Indicated for use as a bone void filler and bone graft substitute for non-structural osseous defects in the extremities and pelvis, including surgically created defects or those resulting from traumatic injury.

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

• DBX® Demineralized Bone Matrix Putty (K040262)
• Grafton® DBM (K051195)

Submission Summary (Full Text)

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# SEP 1 1 2009

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

## General Company Information

- Name: Bacterin International, Inc. Contact: Howard Schrayer Regulatory Affairs Consultant
- Bacterin International, Inc. Address: 600 Cruiser Lane Belgrade, MT 59714
- [phone] Telephone: (406) - 388 - 0422 Fax:

May 4, 2009 Date Prepared

#### General Device Information

OsteoSelect™ Demineralized Bone Matrix Putty Product Name:

"Osteoinductive Bone Void Filler W/O Human Growth Factor", Classification: 21 CFR 888.3045 - Product code: MBP Class II

## Predicate Devices

DBX® Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation 510(k) K040262

Grafton® DBM Osteotech, Inc. 510(k) K051195

#### Description

OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate

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buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

OsteoSelect™ DMB Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.

#### Intended Use (Indications)

OsteoSelect™ DBM Putty is indicated for use as a bone void filler for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of the bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

## Substantial Equivalence

This submission supports the position that OsteoSelectтм Demineralized Bone Matrix Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

DBX@ Demineralized Bone Matrix Putty - Musculoskeletal Transplant Foundation [510(k) K040262]

Grafton® DBM - Osteotech, Inc. [510(k) K051195]

The 510(k) Notice contains summaries of physical test results, functionality (efficacy testinq) results and biocompatibility testing. The methods used for processing the DBM used in the device have been tested and validated for viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes was evaluated. The processing methods were determined to provide significant viral inactivation potential for a wide range of viruses.

OsteoSelect™ DBM Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic rat model. Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model for osteoinductive potential. It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance.

The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.

Bacterin International, Inc. % Mr. Howard L. Schrayer 600 Cruiser Lane Belgrade, Montana 59714

FP 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Re: K091321

Trade Name: OsteoSelect™ Demineralized Bone Matrix Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Regulatory Class: II Product Code: MQV, MBP Dated: July 9, 2009 Received: July 14, 2009

Dear Mr. Schrayer:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Howard L. Schraver

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Qerbare Brehup

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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: OSTEOSELECT™ Demineralized Bone Matrix Putty

Indications For Use:

OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091321