OsteoSelect PLUS Demineralized Bone Matrix Putty

K150621 · Bacterin International, Inc. · MQV · Aug 18, 2015 · Orthopedic

Device Facts

• Record ID: K150621
• Device Name: OsteoSelect PLUS Demineralized Bone Matrix Putty
• Applicant: Bacterin International, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoSelect® PLUS 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® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows: Extremities, Pelvis, Posterolateral spine.

Device Story

OsteoSelect® PLUS DBM Putty is a bone graft substitute composed of processed, demineralized human bone combined with an absorbable carrier (carboxymethylcellulose and phosphate buffered saline). The device provides a putty-like consistency for ease of application during orthopedic surgery. It is used by surgeons to fill osseous defects in the extremities, pelvis, or posterolateral spine. The device is biocompatible and biodegradable; it is intended to fill voids not intrinsic to bony stability. The putty is designed to be spreadable with minimal adhesion to surgical gloves. Clinical benefit is derived from its osteoinductive potential, which is verified for each lot via rodent model testing post-gamma sterilization. The device is supplied as a sterile product.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing and animal studies. Bench testing evaluated extrusion, shelf-life handling, cohesiveness, and performance under irrigation. Biocompatibility was established per ISO 10993. Viral inactivation potential was validated against a panel of model human viruses. Osteoinductive potential is verified for each lot using a rodent model.

Technological Characteristics

Material: Demineralized human bone, carboxymethylcellulose, phosphate buffered saline. Form: Putty. Sterilization: Gamma irradiation. Biocompatibility: ISO 10993 compliant. Performance: Evaluated for extrusion, cohesiveness, and handling. Osteoinductive potential: Rodent model testing.

Indications for Use

Indicated for patients requiring bone graft substitutes for non-structural osseous voids or gaps resulting from surgery or traumatic injury in the extremities, pelvis, or posterolateral spine.

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, K130498)

Reference Devices

• DBX® MIX Demineralized Bone Matrix Putty (K063676)
• Progenix Plus Bone Void Filler Device (K082002)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of three faces in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the image.

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

August 18, 2015

Bacterin International Incorporated Mr. Howard L. Schraver 600 Cruiser Lane Belgrade, Montana 59714

Re: K150621

Trade/Device Name: OsteoSelect® PLUS 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: MQV, MBP Dated: June 17, 2015 Received: June 18, 2015

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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)

{1}------------------------------------------------

Page 2 - Mr. Howard L. Schrayer

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) く150621

Device Name

OsteoSelect® PLUS Demineralized Bone Matrix Putty

Indications for Use (Describe)

OsteoSelect® (DBM) Putty is indicated for use as a 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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary Bacterin International, Inc OsteoSelect® PLUS Demineralized Bone Matrix Putty

#### 1.0 Manufacturer Name

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

#### 2.0 Contact

Howard Schrayer Regulatory Consultant Phone: [phone] E-mail: [e-mail]

#### 3.0 Date Prepared: August 14, 2015

#### 4.0 Device Name and Classification

| Proprietary Name: | OsteoSelect® PLUS Demineralized Bone Matrix Putty |
|--------------------|---------------------------------------------------------|
| Common/Usual Name: | Bone void filler |
| Classification: | Osteoinductive Bone Void Filler W/O Human Growth Factor |
| Regulation Number: | 21 CFR 888.3045 |
| Device Class: | II |
| Product Code: | MBP and MQV |

#### 5.0 Indications for Use

OsteoSelect® PLUS 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® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows:

- Extremities ●
- . Pelvis
- Posterolateral spine ●

{4}------------------------------------------------

#### 6.0 Device Description

OsteoSelect® PLUS 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® PLUS DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.

#### 7.0 Predicate Devices

| Primary Predicate | OsteoSelect® Demineralized Bone Matrix Putty<br>Bacterin International, Inc.<br>K091321 (use in extremities and pelvis)<br>K130498 (use in posterolateral spine) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| References | DBX® MIX Demineralized Bone Matrix Putty<br>Musculoskeletal Transplant Foundation K063676<br><br>Progenix Plus Bone Void Filler Device<br>Medtronic Sofamor Danek K082002 |

#### 8.0 Comparison to Predicate Devices

The device characteristics and indications for use of the OsteoSelect® PLUS DBM Putty are similar or the same as the predicate device.

#### 9.0 Biocompatibility and Performance Testing

The 510(k) Notice contains summaries of manufacturing procedures, physical test results, shelf life testing, functionality (efficacy testing) results and biocompatibility testing previously conducted on the OsteoSelect® DBM Putty predicate. OsteoSelect® PLUS DBM Putty was deemed biocompatible based on this prior comprehensive biocompatibility testing performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.

The process used to make Demineralized Bone Matrix for OsteoSelect® DBM Putty was validated for its ability to inactivate and/or clear a panel of model human enveloped and non-enveloped viruses representing DNA- and RNAcontaining viruses and various viral shapes and sizes. This testing demonstrated the process provides suitable viral inactivation potential for a wide spectrum of potential human viruses. Other testing and justification was provided in support of an adequate viral inactivation process with successful inactivation potential of the modified particle size formulation. This inactivation potential provides

{5}------------------------------------------------

additional viral contamination risk reduction beyond that provided through donor screening and sterilization.

Based on the change to the DBM particle size distribution, OsteoSelect® PLUS DBM Putty was tested to evaluate extrusion from a syringe, maintenance of consistent handling characteristics for the duration of shelf life, performance under irrigation, cohesiveness while packing behavior into void spaces, and handling without sticking to surgical gloves. The results of these evaluations provide evidence supporting the suitability of the device for its intended use.

Each lot of OsteoSelect® PLUS DBM Putty is also tested for osteoinductive potential in a rodent model after gamma sterilization as part of the release criteria.

A comprehensive battery of OsteoSelect DBM Putty non-clinical testing, including chemical, physical, and animal, is additionally referenced and replied upon for the evaluation of the OsteoSelect® PLUS DBM Putty.

Testing has provided a reasonable assurance of safety and efficacy for the intended use of the device, and supports a determination of substantial equivalence.

#### 9.0 Conclusion

Bacterin International, Inc. believes that the information provided establishes that the OsteoSelect® PLUS DBM Putty device is similar with respect to indications for use, design, function, and fundamental scientific technology to legally marketed devices and that there are no new concerns of safety or efficacy. Therefore, it is concluded that the subject device is substantially equivalent to the predicate.