MBCP

K032268 · Biomatlante · MQV · Dec 11, 2003 · Orthopedic

Device Facts

• Record ID: K032268
• Device Name: MBCP
• Applicant: Biomatlante
• Product Code: MQV · Orthopedic
• Decision Date: Dec 11, 2003
• 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 bony structure. 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.

Device Story

MBCP is a biphasic bone graft substitute composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate; available as granules or blocks. Used by surgeons in clinical settings to fill non-structural bony voids or gaps in the skeletal system (extremities, spine, pelvis). Device lacks initial mechanical strength; requires rigid fixation techniques for stabilization. Implant is packed into the defect site; provides a microporous and macroporous scaffold mimicking cancellous bone. Gradually resorbs over time; replaced by natural bone during healing process. Radiopaque; may mask underlying pathology on imaging. Benefits patient by facilitating bone repair in traumatic or surgical defects.

Clinical Evidence

Bench testing and animal studies provided. Chemical safety confirmed via ASTM standards for ceramic hydroxylapatite. Biocompatibility documented as non-toxic, non-allergenic, and non-inflammatory. Animal study (canine model) evaluated osseous rehabilitation; histological and radiological analysis at 6 weeks showed bone ingrowth into implant macropores and transformation into new cortical bone with active remodeling.

Technological Characteristics

Biphasic calcium phosphate (60% hydroxyapatite, 40% beta-tricalcium phosphate). Microporous and macroporous structure. Provided sterile for single-patient use. Radiopaque. Conforms to ASTM standards for heavy metals and trace elements in ceramic hydroxylapatite.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Applicable to surgically created or traumatic osseous defects. Contraindicated for structural support, osteomyelitis, necrotic surgical sites, degenerative bone disease, and intra-articular implantations.

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

• Vitoss (K994337)
• Mastergraft (K020986)
• ProOsteon 500R (K990131)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date December 11, 2003. The month is represented by the abbreviation DEC. The day is 11 and the year is 2003. The text is in a bold, sans-serif font.

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K032268'. The characters are handwritten in a bold, somewhat rough style, giving them a distinct and informal appearance. The contrast between the characters and the background is high, making them easily readable.

Image /page/0/Picture/2 description: The image shows a logo with the word "BIOMATLANTE" in a stylized font. The text is positioned to the right of a curved graphic element that resembles a stylized letter or symbol. The overall design is simple and clean, with a focus on the text and the accompanying graphic.

-Confidential-

МВСР pending тм

# 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 address : | BIOMATLANTE<br>ZA DES IV NATIONS<br>5, rue Edouard Belin<br>-F- 44360 VIGNEUX DE BRETAGNE<br>France |
|--------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact : | Myriam VINCENT, Chemical Engineer<br>Tel : [phone]<br>[e-mail] |
| FDA Establishment Number : | not known |
| 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 :

Revised December 9, 2003

# 2. PREDICATE DEVICES

| Product Code | Manufacturer | 510(k) # | Product |
|--------------|-------------------------|----------|----------------|
| MQV | Orthovita | K994337 | Vitoss |
| MQV | Sofamor Danek | K020986 | Mastergraft |
| MQV | Interpore International | K990131 | ProOsteon 500R |

# 3. DEVICE DESCRIPTION

MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium MDOT - 10 a Bono gran consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (β-TCP). MBCP™ is available in granules or blocks. MBCP™ is provided sterile for single patient use.

Rev. 12/08/2003

{1}------------------------------------------------

-Confidential-

Image /page/1/Picture/1 description: The image shows the word "BIOMATLANTE" in bold, italicized font. Above the word is a black hexagon shape. To the left of the hexagon is a curved shape that resembles a crescent moon.

MBCP pending тм

# 510(k) Summary of Safety and Effectiveness

MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human MBCP™ presents a multuriectional intervennoted ing the remodeling and bone defect repair cancellous bone. MBCP "" implant slowly teserbe dailing the vol. The progressive resorption of process and 15 progress.very of tiller is intended to prevent premature resorption.

# 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 structures (e.g. extremines, spine and pervice that are manage to osseous defects created from traumatic injury to the bone.

tradinatic injury to the bone. may often be recommended.

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

# 5. CONTRAINDICATIONS

MBCP™ has limited initial mechanical properties. Therefore, this product is contraindicated where the device is intended as structural support in the skeletal system.

Conditions representing contraindications include also :

- . osteomyelitis
- implantation in necrotic surgical sites .
- degenerative bone disease .
- intra-articular implantations .

### 6. ADVERSE EFFECTS

Possible adverse effects include but are not limited to :

- Wound complications including hematoma, infection, and other complications that are . possible with any surgery
- possible with any ourgery . filler

### 7. WARNINGS AND PRECAUTIONS

Rigid fixation techniques may be required to assure rigid stabilization of the defect in all planes. Maximum contact between the product and the recipient bone must be established. The implantation in a revision surgical site containing non-resorbable fragments of material (e g. polyethylene ligament waste, carbon fibers) are not recommended.

polyethylene igament waste, care should be exercised in treating individuals with preexisting As with any surgical procedure, care one of the surgical procedure. This includes (but is not limited

{2}------------------------------------------------

-Confidential-

Image /page/2/Picture/1 description: The image shows a logo with a stylized graphic element on the left, resembling a curved shape with a textured or grainy fill. Above the text, there is a solid black hexagon. To the right of the graphic is the word "BIOMATLANTE" in a bold, sans-serif font. The overall design appears to be a company logo or brand mark.

MBCP pending тм

# 510(k) Summary of Safety and Effectiveness

to) individuals with long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism.

MBCP™ is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. MDGT - Is fadiopaque until rootibelly assess the ingrowth of new bone.

MBCP™ is intended for use by surgeons familiar with bone grafting and rigid fixation techniques.

# 8. SAFETY AND EFFECTIVENESS SUMMARY

### 8.1. Chemical safety

Chemical safety of MBCP™ is based on the recognized consensus standard specification, ASTM Chemical Salety of MDOT - 13 baced on the Feesghized of Ceramic Hydroxylapatite for Surgical Implants. MBCP™ conforms to the required specifications for heavy metals trace elements level.

### 8.2. Biocompatibility

The biocompatibility of HA, B-TCP, mixture of both and MBCP™ is well documented. All these The blocompanibility of The preven to be non toxic, non allergenic, biocompatible and elicits no inflammation. No adverse effect or foreign body reaction have been reported.

### 8.3. Osseous rehabilitation

Radiological, histological and analytical techniques were used to evaluate the bone ingrowth in Nadiological, filstologiour and andryted. contines of dogs [1]. After 6 weeks, the bone ingrowth appeared essentially in the cortical part of the implant, invading all implant macropores. ingrowth appeared oboomially in the implant was transformed into new cortical bone and bone remodelling was observed.

# 9. SUBSTANTIAL EQUIVALENCE

The device is substantially equivalent based on similar material characteristics and the same intended use. In addition, animal studies and clinical data with the device support its safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2003

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

Re: K032268

Trade 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: October 31, 2003 Received: November 5, 2003

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. You must comply with all the Act's requirements, including, but not limited to: registration

{4}------------------------------------------------

Page 2 - Ms. Myriam VINCENT

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/dsma/dsmamain.html

Sincerely vours.

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

{5}------------------------------------------------

# MBCP pending TM

# Indications for Use

#### 510(k) Number: K032268

Device Name: MBCP pending TM

#### 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 bony structure. 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.

#### Contraindications:

MBCP™ has limited initial mechanical properties. Therefore, this product is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing contraindications include also :

- . osteomyelitis
- implantation in necrotic surgical sites .
- degenerative bone disease .
- intra-articular implantations .

Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">or</div> | Over the Counter Use |
|------------------|------------------------------------------|----------------------|
|------------------|------------------------------------------|----------------------|

| Rev. 12/08/2003 | Section 03<br>Page 1 of 1 |
|-----------------|---------------------------|
|-----------------|---------------------------|

for Mark N Millikin
of Cranial, Restorative
Neurological Devices

| K Number: | K032268 |
|-----------|---------|
|-----------|---------|