MBCP

K051774 · Biomatlante · MQV · Jan 20, 2006 · Orthopedic

Device Facts

• Record ID: K051774
• Device Name: MBCP
• Applicant: Biomatlante
• Product Code: MQV · Orthopedic
• Decision Date: Jan 20, 2006
• 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). It features a microporous and macroporous structure designed to facilitate bone ingrowth. The device is supplied as granules in vials or syringes and is intended for single-patient use. It is applied by a surgeon into bony voids or gaps; it may be mixed with saline, patient serum, whole blood, or bone marrow aspirate. The material lacks intrinsic mechanical strength, necessitating the use of rigid fixation (plates/screws) and post-operative immobilization. Over time, the ceramic resorbs and is replaced by natural bone tissue. It serves as a bone void filler or graft extender in orthopedic procedures, including osteotomies.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material composition, and intended use compared to previously cleared predicate devices.

Technological Characteristics

Biphasic calcium phosphate ceramic (60% hydroxyapatite, 40% beta-tricalcium phosphate). Microporous and macroporous structure. Supplied sterile for single-patient use. Form factor: granules in vials or syringes. Resorbable material.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability, including surgically created or traumatic osseous defects. Also indicated for use in femoral or tibial osteotomies when used with appropriate fixation devices. Not for use where structural stability 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

• MBCP™ (K032268)
• MBCP™ (K043005)

Submission Summary (Full Text)

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K 051774

MBCPTM

-Confidential-

# 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: | MBCP™ |
| 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:

October 18th, 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™ granules are packaged in vials or syringes.

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.

Rev. 10/18/2005

Section 04 Page 1 of 2

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-Confidential-

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МВСРТМ

# 510(k) Summary of Safety and Effectiveness

#### 4. 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 but that are not intrinsic to the stability of the bony structure. created osed 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 ostedtomy 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.

#### SUBSTANTIAL EQUIVALENCE INFORMATION 5.

The intended use and material composition of MBCP™ Bone Graft Substitute is the same as previously cleared MBCP™ (K032268, K043005). 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the top half of the circle.

Public Health Service

JAN 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Myriam Vincent Chemical Engineer BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin VIGNEUX DE BRENTAGNE -F-44360 France

Re: K051774

МВСРТМ

Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: October 18, 2005 Received: October 24, 2005

Dear Ms. VINCENT:

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.

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Page 2 - Ms. Myriam Vincent

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 your 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.

Mark N. Mall

Mark N. Melkerson. જ્ઞ 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): K051774

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 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.

| Prescription Use<br>AND/OR<br>Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">✓</span> |
|----------------------------------------------------------|----------------------------------------------------|
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | <span style="text-decoration: underline;"></span> |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrantes Rif Start Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

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510(k) Number K051334