BIOFILL BONE VOID FILLER

K040454 · Scient'X · MQV · May 7, 2004 · Orthopedic

Device Facts

• Record ID: K040454
• Device Name: BIOFILL BONE VOID FILLER
• Applicant: Scient'X
• Product Code: MQV · Orthopedic
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biofill is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Biofill is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Biofill should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Biofill is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Story

Biofill Bone Void Filler is a tricalcium phosphate scaffold used to fill non-structural osseous defects. Supplied as parallelepiped granules (1-4mm size) with 60-80% macroporosity (200-700μm pores) and microporosity (<5μm). Intended for surgical use by physicians to fill voids in extremities, spine, and pelvis. The material is packed into the defect site; it acts as a scaffold that resorbs over time and is replaced by natural bone during the healing process. No electronic or mechanical components.

Clinical Evidence

Bench testing only. Compliance with ASTM F1088-87 standard specification for beta tricalcium phosphate for surgical implantation.

Technological Characteristics

Material: Beta tricalcium phosphate (compliant with ASTM F1088-87). Form: Parallelepiped granules (1-4mm). Porosity: 60-80% macroporosity (avg 400μm), microporosity <5μm. Non-electronic, passive implantable device.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) where the defect is not intrinsic to bony stability. Contraindicated for large defects that would not heal spontaneously.

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

• BIOSORB (K021963)
• Vitoss™ Scaffold (K994337)

Submission Summary (Full Text)

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KD40454

## 510(k) Summary - Revised

Date April 28, 2004

Submitter Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE

Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

### Common name

Bone void filler

### Classification name

Filler, calcium sulfate, preformed pellets

### Equivalent Device

Biofill is equivalent in material, indications and use as BIOSORB (K021963) (Sciences et Bio Materiaux, Lourdes, France) and Vitoss™ Scaffold (K994337) (Orthovita, Inc. (Malvern PA).

### Device Description

Biofill Bone Void Filler is a tricalcium phosphate bone void filler.

It is supplied in the form of parallelevined granules measuring 1mm-4mm on each side. It is marketed in quantities of Scc, 10cc and 15cc dosages.

The Biofill structure is made up of intercomected macroporcs occupying 60-80% of the granule. Pore size is 200-700um with an average of 400μm. Microporosity is also present with pore size < Sum.

### Intended Üse

Biofill Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, Biofill Bone Void Filler is indicated for use in the treatment of surgically created osscous defects or osseous defects created from traumatic injury to bone. Biofill Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Biofill Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process

### Summary Nonclinical Tests

The material described in this submission complies with ASTM F1088-87, "Standard specification for beta tricalcium phosphate for surgical implantation".

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, positioned to the right. To the left of the figure, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the edge of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 7 2004

Scient'x C/o J. D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K040454

Trade/Device Name: Biofill Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MOV Dated: February 19, 2004 Received: February 24, 2004

Dear Mr. Webb:

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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Page 2 - J. D. Webb

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 n Mellaan

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):K040454

Device Name: Biofill Bone Void Filler

Indications for Use:

Biofill is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Biofill is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Biofill should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Biofill is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Melleum

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

510(k) Number K040654