TRI-OSTETIC

K041889 · Berkeley Advanced Biomaterials, Inc. · MQV · Aug 19, 2004 · Orthopedic

Device Facts

• Record ID: K041889
• Device Name: TRI-OSTETIC
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Tri-Ostetic is a sterile, osteoconductive, bioresorbable, radio-opaque bone void filler. Supplied as a powder and distilled water in separate containers; mixed to form a paste. Applied by hand or syringe into skeletal voids/gaps. Used by surgeons in clinical settings to fill non-structural defects and augment hardware. Acts as a temporary support medium; resorbs as bone ingrowth occurs. Benefits include biocompatibility and ease of application.

Clinical Evidence

No clinical data. Substantial equivalence is supported by materials data and bench testing.

Technological Characteristics

Osteoconductive bone void filler composed of calcium-based compounds and distilled water. Supplied as sterile powder and liquid for single-patient use. Radio-opaque, bioresorbable material. Form factor: putty/paste. No electronic or software components.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the extremities, spine, pelvis, or cranium. Used as a temporary support medium to augment hardware for bone fragment support. Not for structural support 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

• Cem-Ostetic™

Submission Summary (Full Text)

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## AUG 1 9 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 use of the Tri-Ostetic Bone Void Filler.

| Submitted By: | Berkeley Advanced Biomaterials Inc. |
|-------------------------------------|-----------------------------------------------------------------|
| Date: | 07-06-04 |
| Contact Person: | François Génin, Ph.D.<br>Phone: [phone]; Fax: [phone] |
| Proprietary Name: | Tri-Ostetic |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | Orthopedics/87/MQV |

#### DEVICE INFORMATION

#### A. INTENDED USES/INDICATIONS

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

#### B. DEVICE DESCRIPTION

Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

Tri-Ostetic is substantially equivalent to the legally marketed, predicate device Cem-Ostetic™. 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 Tri-Ostetic are very similar to that of the predicate device. The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market Notification.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

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

Re: K041889

Trade/Device Name: Tri-Ostetic Regulation Number: 21 CFR 888.3034 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: August 1, 2004 Received: August 3, 2004

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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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/dsma/dsmamain.html

Sincerely yours,
Mark A Milken

Celia M. Witten, PhD, MD 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): K041889

#### Device Name: Tri-Ostetic

Indications For Use:

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

| Prescription Use | <div> <object> <svg> </svg> </object> </div> |
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AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) | |
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O Mark A Milhurn

Restorative, and Neurological Devices

K041889

510(k) Number_

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