CAP BONE SUBSTITUTE MATERIAL

K032307 · Etex Corp. · GXP · Oct 24, 2003 · Neurology

Device Facts

• Record ID: K032307
• Device Name: CAP BONE SUBSTITUTE MATERIAL
• Applicant: Etex Corp.
• Product Code: GXP · Neurology
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².

Device Story

Synthetic, biocompatible calcium phosphate (CaP) bone graft substitute; supplied as kit. Clinician mixes powder with U.S.P. 0.9% Sodium Chloride in elastomeric bulb to form paste. Paste applied manually to cranio-maxillo-facial surgical sites; shaped in situ. Hardens at body temperature into poorly crystalline hydroxyapatite (PCHA). Osteoconductive; resorbed and replaced by natural bone over time. Used in surgical settings for bone defect repair.

Technological Characteristics

Synthetic calcium phosphate; converts to poorly crystalline hydroxyapatite (PCHA) in situ. Supplied as sterile, single-use kit. Mixing requires manual kneading with 0.9% Sodium Chloride. Osteoconductive material.

Indications for Use

Indicated for filling, repair, reconstruction, and augmentation of burr holes, craniotomy cuts, and craniofacial bone defects (fronto-orbital, malar, mental) with surface area ≤ 25cm².

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• a-BSM® Bone Substitute Material (K983009)

Submission Summary (Full Text)

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## OCT 2 4 2003

# SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR: | ETEX Corporation |
|----------------------|---------------------------------------|
| | 38 Sidney Street, 3rd Floor |
| | Cambridge, MA 02139 |
| | Phone: [phone] x236 |
| | Fax: [phone] |
| 510(k) CONTACT: | Kristine Canavan |
| | Manager, Regulatory Affairs |
| TRADE NAME: | CaP Bone Substitute Material |
| COMMON NAME: | Bone Graft Material |
| | Bone Substitute Material |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | 21 CFR 882.5300 |
| | Methyl Methacrylate for Cranioplasty |
| PRODUCT CODE: | 87 GXP |
| PREDICATE DEVICES: | a-BSM® Bone Substitute Material |
| | 510(k) No.: K983009, ETEX Corporation |

### DEVICE DESCRIPTION:

Calcium Phosphate (CaP) Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in cranial-maxillo-facial surgical repair applications. At the time of use, the CaP product material is combined with the mixing liquid (U.S.P. Sodium Chloride, 0.9%) in the elastomeric mixing bulb, and is mixed, using a kneading technique, to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the

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paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

#### INDICATIONS FOR USE:

CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².

### BASIS OF SUBSTANTIAL EQUIVALENCE:

CaP Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to α-BSM Bone Substitute Material (OMF). Both materials are provided sterile and as single patient, single use kits and are identical in intended use (i.e., cranio-maxillo-facial indications). CaP Bone Substitute Material is also similar to α-BSM Bone Substitute Material (OMF) in material properties and in product performance characteristics. Differences between the CaP and a-BSM products do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 2 4 2003

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine Canavan Manager, Regulatory Affairs ETEX Corporation University Park at MIT 38 Sidney Street Cambridge, MA 02139

Re: K032307

Trade Name: CaP Bone Substitute Material Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 24, 2003 Received: July 28, 2003

Dear Ms. Canavan:

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 - Ms. Kristine Canavan

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.

Sincerely yours,

Mark A. Millam

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

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**510(k) Number (if known)**

K032307

Device Name: CaP Bone Substitute Material

#### Indications for Use:

CaP Bone Substitute Material is an implantable bone graft, that is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm .

Concurrence of CDRH, Office of Device Evaluation

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Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

for Mark N. Millburn

vision Sign-Off) Frision of General, Restorative and Neurological Devices

Number K03 2307