OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

K130498 · Bacterin International, Inc. · MBP · May 31, 2013 · Orthopedic

Device Facts

• Record ID: K130498
• Device Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Applicant: Bacterin International, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: May 31, 2013
• 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 and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: Extremities . Posterolateral spine . Pelvis .

Device Story

OsteoSelect® DBM Putty is a bone void filler composed of processed human demineralized bone matrix (DBM) combined with an absorbable carrier (carboxymethylcellulose and phosphate buffered saline). The device provides a putty-like consistency for surgical application. It is used by surgeons to fill osseous defects or gaps in the extremities, posterolateral spine, and pelvis. The material is osteoconductive and is absorbed by the body within 90 days. The device is supplied sterile and is intended for single-use application during orthopedic procedures to support bone healing.

Clinical Evidence

Bench testing included viral inactivation validation, shelf-life testing, and functionality/efficacy testing. Biocompatibility was established per FDA guidelines. Osteoinductivity was confirmed via in vivo athymic rat model testing for every final lot. An in vivo study was conducted to support use in the posterolateral spine. No human clinical trial data provided.

Technological Characteristics

Composition: Processed human demineralized bone matrix (DBM) with carboxymethylcellulose and phosphate buffered saline carrier. Form factor: Putty. Properties: Osteoconductive, biodegradable (resorption within 90 days). Sterilization: Validated viral inactivation processing methods.

Indications for Use

Indicated for use as bone void filler and bone graft substitute in patients with surgically created osseous defects or traumatic bone injuries in the extremities, posterolateral spine, or pelvis. Not for use in voids intrinsic to bony structure stability.

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

• OsteoSelect® Demineralized Bone Matrix Putty (K091321)
• DBX® Demineralized Bone Matrix Putty (K103784)
• DBX® Demineralized Bone Matrix Putty (K103795)

Submission Summary (Full Text)

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## 510(k) SUMMARY (Per 21 CFR 807.92)

# MAY 3 1 2013

## General Company Information

| Name: | Bacterin International, Inc. |
|----------|--------------------------------------------------|
| Contact: | Howard Schrayer<br>Regulatory Affairs Consultant |

Address: Bacterin International, Inc. 600 Cruiser Lane Belgrade, MT 59714

| Telephone: | [phone] |
|------------|----------------|
| Fax: | [phone] |

Date Prepared May 30, 2013

## General Device Information

| Product Name: | OsteoSelect® Demineralized Bone Matrix Putty |
|-----------------|-------------------------------------------------|
| Common Name: | Bone Void Filler |
| Classification: | Resorbable calcium salt bone void filler device |

21 CFR 888.3045 - Product code: MBP, MQV

Class II

## Predicate Devices

OsteoSelect® Demineralized Bone Matrix Putty Bacterin International, Inc. 510(k) K091321 (use in extremities and pelvis)

DBX® Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation K103784 (use in pelvis and extremities) K103795 (use in posterolateral spine)

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## Description

OsteoSelect® DBM 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 (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

OsteoSelect® DBM 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 and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows:

- Extremities .
- Posterolateral spine .
- Pelvis .

#### Substantial Equivalence

This submission supports the position that OsteoSelect® DBM Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

OsteoSelect® Demineralized Bone Matrix Putty - Bacterin International, Inc. [510(k) K0913211

DBX® Demineralized Bone Matrix Putty - Musculoskeletal Transplant Foundation {510(k) K103784]

The 510(k) Notice contains summaries of manufacturing procedures, physical test results, shelf life testing, functionality (efficacy testing) results and biocompatibility testing that was previously conducted on the OsteoSelect® DBM Putty predicate. 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

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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.

In addition, the Notice contains a report of an in vivo study that was conducted to support use of OsteoSelect® DBM Putty in the posterolateral spine.

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

### Conclusions

Bacterin International, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the OsteoSelect® DBM Putty. The materials from which the Bacterin device is fabricated have an established history of clinical use, and the device has been tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: May 31, 2013

Bacterin International, Incorporated % Mr. Howard Schrayer Regulatory Affairs Consultant 600 Cruiser Lane Belgrade, Montana 59714

Re: K130498

Trade/Device Name: OsteoSelect® Demineralized Bone Matrix Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP. MOV Dated: March 19, 2013 Received: March 20, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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### Page 2 - Mr. Howard Schraver

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours.

# Mark Nighterson -S

Mark N. Melkerson Director Division.of Orthopedic Devices_ Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K130498

## 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 that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

OsteoSelect® DBM Putty can be used as follows:

- Extremities .
- Posterolateral spine
- Pelvis

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)

Laurence Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130498