BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

K092046 · Berkeley Advanced Biomaterials, Inc. · MQV · Mar 24, 2010 · Orthopedic

Device Facts

• Record ID: K092046
• Device Name: BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Mar 24, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

Device Story

Bi-Ostetic Foam and Putty is a mineralized collagen matrix bone void filler; functions as a scaffold for new bone growth; resorbs during healing. Intended for surgical or traumatic bony voids in extremities, posterolateral spine, and pelvis. Applied by clinician via gentle packing into defect. In weight-bearing sites, must be used with internal or external fixation. Maximum defect size 30 mL. Provides osteoconductive scaffold to facilitate natural bone regeneration.

Technological Characteristics

Mineralized collagen matrix; bovine fibrillar collagen component; resorbable bone void filler; scaffold structure.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, posterolateral spine, pelvis) that are not intrinsic to bony stability. For use in defects up to 30 mL; requires internal or external fixation in weight-bearing applications.

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.

Submission Summary (Full Text)

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K092046 MAR 24 2010

BERKELEY ADVANCED BIOMATERIALS, INC.

901 Grayson Street, Suite 101. Berkeley. CA 94710. USA Tel: [phone]; Fax: [phone] Email: [e-mail] http://www.hydroxyapatite.com

Image /page/0/Picture/3 description: The image shows a circular arrangement of circles that vary in size. The circles are arranged in concentric rings, with the smallest circles located at the center and the largest circles located at the periphery. The size of the circles gradually increases from the center to the periphery. The arrangement of the circles creates a visual effect of depth and perspective.

## 510(K) Summary Statement for Bi-Ostetic Foam and Putty

In accordance with the Food and Drug Admisnistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the device.

| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|--------------------------|-------------------------------------------------|
| Date: | 2 July 2009 |
| Contact Person: | François Génin, Ph.D. |
| Position: | Chief Executive Officer |
| Contact Information | Phone: [phone]; Fax: [phone] |
| Proprietary Name: | Bi-Ostetic Foam and Putty |
| Regulation Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Regulation Number: | 888.3045 |
| Classification: | Class II |
| Device Code/ Panel Code: | Orthopedics/87/MQV |

### DEVICE INFORMATION

#### A. INTENDED USE

Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

#### B. DEVICE DESCRIPTION

The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, materials and design features of the device are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the devices are adequately supported by the substantial equivalence information provided within the Premarket Notification.

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

Berkeley Advanced Biomaterials, Inc. c/o Francois Genin, Ph.D. Chief Executive Officer 901 Grayson St., Suite 101 Berkeley, CA 94710

MAR 2 4 2010

Re: K092046

Trade/Device Name: Bi-Ostetic Foam and Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 19, 2010 Received: February 22, 2010

Dear Dr. Genin:

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(fict 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 899. In 11 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 otheron wour not of the Act or any Federal statutes and regulations administered by other Foderal eqencies. 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.

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Page 2 - Francois Genin, Ph.D.

(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 53) -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 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, (2) OED Beach Foregulation 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.

Sincerely yours,

FGR

N. M.

Mark N. Melker 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: K092046

Device Names: Bi-Ostetic Foam and Putty

Indications for Use:

Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sigh-Qiry). Orthopedic.
Division of Suryical, Orthopedic. Division of Sive Devices

K092046

510(k) Number

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