BIOPLUS

K042636 · Berkeley Advanced Biomaterials, Inc. · MQV · Dec 14, 2004 · Orthopedic

Device Facts

• Record ID: K042636
• Device Name: BIOPLUS
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioPlus 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 BioPlus 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. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Story

BioPlus is a sterile, synthetic, calcium-based bone void filler supplied as granules or blocks. It is used by surgeons to fill non-structural bone voids or gaps in the extremities, spine, pelvis, or cranium. The material is manually pressed into the surgical site. It acts as an osteoconductive, temporary support medium that is radio-opaque and bioresorbable, allowing for natural bone ingrowth as the material resorbs. It provides no structural support during the healing process.

Clinical Evidence

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

Technological Characteristics

Synthetic calcium-based bone void filler; supplied as granules or blocks; osteoconductive; bioresorbable; radio-opaque; sterile; single-patient use.

Indications for Use

Indicated for patients requiring bone void filling in the extremities, spine, pelvis, or cranium where the void is not intrinsic to bone stability. Not for use where structural support is required.

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)

Submission Summary (Full Text)

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K042636

## DEC 1 4 2004

### 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 BioPlus Bone Void Filler.

| Submitted By: | Berkeley Advanced Biomaterials Inc. |
|----------------------------------------|-------------------------------------|
| Date: | 09-20-04 |
| Contact Person: | François Génin, Ph.D. |
| Phone: [phone]; Fax: [phone] | |
| Proprietary Name: | BioPlus |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Class II |
| Device Product Code and Panel Code: | Orthopedics/87/MQV |

#### DEVICE INFORMATION

#### A. INTENDED USES/INDICATIONS

BioPlus 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 BioPlus 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. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

#### B. DEVICE DESCRIPTION

BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus 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

BioPlus is substantially equivalent to legally marketed, predicate device Bi-Ostetic™ (K023703). 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 BioPlus 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

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

Re: K042636

Trade Name: BioPlus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: November 19, 2004 Received: November 23, 2004

Dear Dr. Génin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are examance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (. 10) was the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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 may or subject to Sacer as Sateral 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 r loase of actived that i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 Orth 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) I mis letter will unow you to organ maing of substantial equivalence of your device to a legally premaired 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 If you desire specific advice 101 Jour as 101) 276-0120. Also, please note the regulation entitled, Contact the Office of County of County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of Jour Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Sincerely, yours,

Mark A. Millman

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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# Indications for Use

510(k) Number (if known): K_04z 636

Device Name: BioPlus

Indications For Use:

BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical Dior ras is an obtoberient are intended to be used to fill voids and gaps that are not intrinsic to or corner 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 The granules or blocks provide void filling material that acts as a temporary support medium. Diol tas Lianares or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

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)

Mark A. Millican

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

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**510(k) Number** K042636