MBCP+

K063527 · Biomatlante · MQV · Jul 30, 2007 · Orthopedic

Device Facts

• Record ID: K063527
• Device Name: MBCP+
• Applicant: Biomatlante
• Product Code: MQV · Orthopedic
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MBCP* ™ is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP+TM is provided sterile for single patient use.

Device Story

MBCP+ is a resorbable, porous ceramic bone void filler composed of 20% hydroxyapatite and 80% beta-tricalcium phosphate. Designed as a non-structural scaffold, it facilitates bone ingrowth; microporosity (<5µm) allows biological fluid circulation, while macroporosity (>100µm) supports bone formation. Used by surgeons in clinical settings to fill osseous defects or gaps in the skeletal system (extremities, spine, pelvis) that do not require structural stability. The material is resorbed over time and replaced by newly formed bone. Provided sterile for single-patient use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceramic bone void filler; composition: 20% hydroxyapatite, 80% beta-tricalcium phosphate. Porous structure with microporosity (<5µm) and macroporosity (>100µm). Sterile, single-use, non-structural.

Indications for Use

Indicated for use as a bone void filler for non-structural bony voids or gaps in the skeletal system, including extremities, spine, and pelvis, resulting from surgical procedures or traumatic injury.

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

• EOVIA (K040514)
• BONESAVE (K033258)

Submission Summary (Full Text)

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K063527

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MBCP+ ™

## 510(k) Summary

JUL 3 0 2007

BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE Phone: [phone] Fax: [phone]

Contact: Adeline Filliâtre Regulatory Affairs Manager

This summary was prepared on July 2007, 16th

#### 1. DEVICE IDENTIFICATION

| Trade Name: | MBCP+™ |
|-----------------------|----------------------------------------------------|
| Common Name: | Resorbable bone substitute |
| Classification Name : | Resorbable calcium salt bone void filler<br>device |
| Product Code : | MQV |
| Regulatory Status : | Class II |
| CFR Section : | 888.3045 |

### 2. PREDICATE DEVICES

| Product Code | Manufacturer | 510(k) # | Product |
|--------------|---------------------|----------|----------|
| MQV | Orthotec | K040514 | EOVIA |
| MQV | Howmedica Osteonics | K033258 | BONESAVE |

#### 3. DEVICE DESCRIPTION

MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form.

There are two types of porosity in MBCP+TM:

Rev. 7/16/2007

Section 04 Page 1 of 2

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MBCP+ TM

### 510(k) Summary

The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate.

The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.

### 4. INTENDED USE

MBCP* TM is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP+TM is provided sterile for single patient use.

### 5. SUBSTANTIAL EQUIVALENCE INFORMATION

Documentation was provided which demonstrated the MBCP*™ to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, design, material and function.

Rev. 7/16/2007

Section 04 Page 2 of 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Biomatlante % Ms. Adeline Filliatre Regulatory Affairs Manager ZA les IV Nations 5, rue Edouard Belin Vigneux de Brentagne France 44360

Re: K063527

Trade/Device Name: MBCP+ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: May 28, 2007 Received: June 7, 2007

Dear Ms. Filliatre:

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. Iisting 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. Adeline Filliatre

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,
Barbara Burns

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# MBCP+TM

# Indications for Use

510(k) Number (if known): K063527

Device Name: MBCP+ TM

Indications for Use:

MBCP* ™ is intended for use as 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. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP+TM is provided sterile for single patient use.

MBCP+™ is provided sterile for single patient use.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kaubare Breeno

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

Section 03 Page 1 of 1

Rev. 5/28/2007

510(k) Number K063527