CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ

K030266 · Berkeley Advanced Biomaterials, Inc. · MQV · Feb 20, 2003 · Orthopedic

Device Facts

• Record ID: K030266
• Device Name: CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Story

Cem-Ostetic™ is an osteoconductive bone void filler; supplied as cancellous, cortical, or cortico-cancellous granules, blocks, or injectable putty. Used by surgeons to fill non-structural bone voids in extremities, spine, pelvis, or cranium. Granules/blocks pressed by hand; putty shaped by hand or injected via syringe. Acts as temporary support medium; augments hardware; radio-opaque; biocompatible; resorbs as bone ingrowth occurs. Intended for single patient use.

Clinical Evidence

No clinical data; substantial equivalence supported by materials data and bench testing.

Technological Characteristics

Osteoconductive bone substitute; radio-opaque; biocompatible; resorbs in vivo. Formulated as granules, blocks, or putty. Supplied sterile for single patient use.

Indications for Use

Indicated for filling bony voids or gaps not intrinsic to bone structure stability in extremities, spine, pelvis, or cranium.

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

• Cem-Ostetic™ putty (K030266)

Submission Summary (Full Text)

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BERKELEY ADVANCED BIOMATERIALS, INC.

1933 Davis Street, Suite 307, San Leandro, CA 94577, USA Tel: [phone]; Fax: [phone] Email: [e-mail] http://www.hvdroxyapatite.com

FEB 2 0 2003

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KO30266

ISO9001:94/EN4600

#### 510(K) Summary

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 Cem-Ostetic TM Bone Void Filler.

| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|------------------------------------|-------------------------------------------|
| Date: | 15 January 2003 |
| Contact Person: | François Génin, Ph.D. |
| Position: | President and CEO |
| Contact Information | Phone: [phone];<br>Fax: [phone] |
| Proprietary Name: | Cem-Ostetic™ |
| Common Name: | Bone Void Filler (Granules and Blocks) |
| Classification Name and Reference | Unclassified |
| Device Product Code and Panel Code | Orthopedics/87/MQV |

# DEVICE INFORMATION

## A. INTENDED USES/INDICATIONS

Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

## B. DEVICE DESCRIPTION

Cem-Ostetic™ consists of a pre-shaped ready-for-use formulation of cancellous, cortical or cortico-cancellous blocks or granules. The granules or blocks are supplied sterile for single patient use only.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

Cem-Ostetic TM granules and blocks are substantially equivalent to the legally marketed, predicate device Cem-Ostetic™ putty. The products have identical indications-for-use and identical contraindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-Ostetic™ are very similar to that of the predicate device. The safety and effectiveness of Cem-Osteric™ granules and blocks are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Francois Génin, Ph.D. President and CEO Berkeley Advanced Biomaterials, Inc. 1933 Davis Street, Suite 307 San Leandro, California 94577

Re: K030266

Trade/Device Name: Cem-Ostetic"™ Regulatory Class: Unclassified Product Code: MQV Dated: January 21, 2003 Received: January 27, 2003

Dear Dr. Génin:

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 - François Génin, Ph.D.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known):

Device Name: Cem-Ostetic™ bone void filler

Indications for Use:

Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

VO 30266

The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and intected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Mulleus

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number