MODIFICATION TO MBCP

K043005 · Biomatlante · MQV · May 3, 2005 · Orthopedic

Device Facts

• Record ID: K043005
• Device Name: MODIFICATION TO MBCP
• Applicant: Biomatlante
• Product Code: MQV · Orthopedic
• Decision Date: May 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process. In addition, when used with appropriate opening osteotomy system devices, plates and screws. MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.

Device Story

MBCP™ is a synthetic bone graft substitute composed of biphasic calcium phosphate (60% hydroxyapatite, 40% beta-tricalcium phosphate). Provided as a microporous and macroporous ceramic in various shapes/sizes. Used by surgeons in clinical settings to fill bony voids or gaps in the skeletal system (extremities, spine, pelvis) or in femoral/tibial osteotomies. Can be mixed with physiological saline, patient serum, whole blood, or bone marrow aspirate. Device lacks initial mechanical strength; requires rigid fixation and post-operative immobilization. Upon implantation, material gradually resorbs and is replaced by host bone during healing. Benefits include providing a scaffold for bone regeneration in non-load-bearing defects.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material composition, and intended use similarities to the predicate device.

Technological Characteristics

Biphasic calcium phosphate ceramic (60% hydroxyapatite, 40% beta-tricalcium phosphate). Microporous and macroporous structure. Provided sterile for single-patient use. No energy source or software components.

Indications for Use

Indicated for patients requiring bone void filling in the skeletal system (extremities, spine, pelvis) for non-structural defects, including surgically created or traumatic osseous defects. Also indicated for use as a bone graft extender with autograft and as a bone void filler in femoral or tibial osteotomies when used with appropriate fixation devices. Contraindicated for defects intrinsic to the stability of the bony structure.

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

• MBCP™ (K032268)

Submission Summary (Full Text)

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K043005

-Confidential-

MAY - 3 2005 МВСРТМ

# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary for MBCP™ is provided as required per Section 513(1)(3) of the Food. Drug and Cosmetic Act.

### 1. GENERAL INFORMATION

| Submitter's name and adress : | BIOMATLANTE<br>ZA DES IV NATIONS<br>5, rue Edouard Belin<br>-F- 44360 VIGNEUX DE BRETAGNE<br>France |
|-------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact : | Myriam VINCENT,<br>Regulatory Affairs Manager<br>Tel : [phone]<br>[e-mail] |
| FDA Establishment Number : | 3002673655 |
| Trade Name: | MBCPTM |
| Common Name: | Resorbable Calcium Salt Bone Void Filler |
| Classification Name : | Resorbable Calcium Salt Bone Void Filler |
| Product Code : | MQV |
| CFR Section : | 888.3045 |
| Device Panel : | Orthopedic |

Summary preparation date:

April 12th, 2005

## 2. PREDICATE DEVICES

The subject device is substantially equivalent to similar previously cleared devices.

### 3. DEVICE DESCRIPTION

MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes.

MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).

MBCP™ is provided sterile for single patient use.

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<043005

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МВСР™

### -Confidential-

# 510(k) Summary of Safety and Effectiveness

### 4. INTENDED USE

MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

In addition, when used with appropriate opening osteotomy system devices, plates and screws. MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.

### 5. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268). MBCP™ Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction and function.

The safety and effectiveness of MBCP™ Bone Graft Substitute as modified in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification.

Rev. 04/12/2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

MAY - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Myriam VINCENT Regulatory Affairs Manager BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F-44360 VIGNEUX DE BRENTAGNE France

Re: K043005

МВСРТМ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: January 28, 2005 Received: February 2, 2005

Dear Ms. VINCENT:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your ever 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, of to act roomstic Act (Act) that do not require approval of a premarket the Federal 1 00d, Drug, dAS You may, therefore, market the device, subject to the general approvin apprevisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (see ass 10) in a controls. Existing major regulations affecting (1 Mrc), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advisod that i Dr. o losains on that your device complies with other requirements modi that I DA mas mad regulations administered by other Federal agencies.

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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.

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,

Hugh Purvis

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): K043005

Device Name: MBCP™

### Indications For Use:

MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograff as a bone graft extender. These bony be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

tradinato mjary to the without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

In addition, when used with appropriate opening osteotomy system devices, plates and in addition, which is intended to be used as a bone void filler in femoral or tibial osteotomies.

MBCP™ is to be used in association with adequate post-operative immobilization.

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 IF NEEDED)

C

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K043005