GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES

K050666 · Berkeley Advanced Biomaterials, Inc. · MQV · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K050666
• Device Name: GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) 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 GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Story

GenerOs™ is a sterile, synthetic, osteoconductive bone void filler composed of beta-tricalcium phosphate (β-TCP). Supplied as granules or blocks, it is intended for surgical use to fill non-structural bone voids or gaps in the extremities, spine, pelvis, or cranium. The surgeon manually presses the material into the surgical site. The device acts as a temporary support medium and is resorbed by the body as natural bone ingrowth occurs. It is radio-opaque, allowing for radiographic visualization. The device is intended for single-patient use.

Clinical Evidence

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

Technological Characteristics

Material: Beta-tricalcium phosphate (β-TCP). Form: Granules or blocks (cancellous, cortical, or cortico-cancellous). Properties: Osteoconductive, bioresorbable, radio-opaque. Sterilization: Sterile for single-patient use.

Indications for Use

Indicated for filling bony voids or gaps not intrinsic to bone stability in the extremities, spine, pelvis, or cranium. Not for use where structural support is required during healing.

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

• Bi-Ostetic (K023703)
• Vitoss (K994337)

Submission Summary (Full Text)

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BERKELEY ADVANCED BIOMATERIALS, INC.

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

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# 510(K) Summary Statement GenerOs™ Bone Void Filler

☐

nd Drug Admisnistration Rule

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 GenerOsTM Bone Void Filler.

| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|------------------------------------|-------------------------------------------|
| Date: | 10 March 2005 |
| Contact Person: | François Génin, Ph.D. |
| Position: | Chief Executive Officer |
| Contact Information | Phone: [phone];<br>Fax: [phone] |
| Proprietary Name: | GenerOs™ |
| Common Name: | Bone Void Filler |
| Classification | Class II |
| Device Product Code and Panel Code | Orthopedics/87/MQV |

## DEVICE INFORMATION

#### A. INTENDED USES/INDICATIONS

GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) 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 GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.

#### B. DEVICE DESCRIPTION

GenerOs™ is a sterile osteoconductive bone void filler composed of ß-TCP. This synthetic bone graft comes in the shape of granules or blocks. GenerOs™ is supplied sterile for single patient use only. GenerOs™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

GenerOs™ is substantially equivalent to legally marketed, predicate devices Bi-Ostetic (K023703) and Vitoss (K994337). The products have identical indications-for-use, identical or very similar composition, and equivalent contraindications. They also have similar warnings, precautions and potential adverse events. The safety and effectiveness of GenerOs™ are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR ] ] 2005

Dr. Francois Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. 1933 Davis Street, Suite 307 San Leandro, California 94577

Re: K050666

Trade/Device Name: GenerOs™ bone void filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 10, 2005 Received: March 15, 2005

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 - Dr. 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] . 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 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/industry/support/index.html.

Sincerely yours,

Mir

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): K050666

#### Device Name: GenerOs™ bone void filler

Indications For Use:

GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) 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 GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ J (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styck Church

(Division Sign-Of Division of General, Restorative, and Neurological Devices

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510(k) Namber ________________________________________________________________________________________________________________________________________________________________