CARRIGEN

K093447 · Etex Corp. · MQV · Feb 18, 2010 · Orthopedic

Device Facts

• Record ID: K093447
• Device Name: CARRIGEN
• Applicant: Etex Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Story

CarriGen is a synthetic, biocompatible, osteoconductive bone graft substitute. It consists of a powder component mixed with a solution to form a putty. The putty is manually applied to bony voids or gaps in the extremities, spine, or pelvis. Once applied, the material hardens at body temperature, converting into a poorly crystalline, apatitic calcium phosphate hydroxyapatite (PCHA) that mimics natural bone mineral. The material is resorbed and replaced by new bone during the healing process. It is used by surgeons in clinical settings to treat surgically created or trauma-induced osseous defects that do not require structural stability.

Clinical Evidence

No clinical data. Performance demonstrated via regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device.

Technological Characteristics

Synthetic calcium phosphate, sodium carboxymethyl cellulose, sodium bicarbonate, and sodium carbonate. Self-setting, injectable, macro-porous putty. Hardens at body temperature to form poorly crystalline apatitic calcium phosphate hydroxyapatite (PCHA).

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, posterolateral spine, pelvis) not intrinsic to structural stability. Applicable to surgically created osseous defects or those resulting from traumatic injury. For prescription use only.

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

• OssiPro (K062630)
• EquivaBone Osteoinductive Bone Graft Substitute (K090855)
• Gamma-bsm Moldable Bone Substitute Material (K091607)

Submission Summary (Full Text)

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10934477

Special 510(k) Submission - CarriGen (OssiPro) Modification

## 5. 510(k) Summary

## FEB 1 8 2010

FEB 18 2010

| Submitter: | ETEX Corporation<br>38 Sidney Street<br>Cambridge, MA 02139<br>Registration No.: 1225112<br>Owner/Operator No.: 9014709 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Regulatory Affairs Manager<br>Office: [phone] x160<br>Mobile: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | November 4, 2009 |
| Product Code(s): | MQV (21 CFR 888.3045) |
| Device Class: | II (21 CFR 888.3045) |

Classification Panel: Orthopaedics

FDA Panel Number: 87

Classification Name: Filler, Bone Void, Calcium Compound (21 CFR 888.3045)

Proprietary Name: CarriGen® Porous Bone Substitute Material

Predicate Device(s): OssiPro (ETEX Corp., K062630)
EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corp., K090855)
Gamma-bsm Moldable Bone Substitute Material (ETEX Corp., K091607)

Device Description: CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form *in-situ* prior to implantation. After the putty is applied to the treatment site, it hardens at body

temperature and converts to an apatitic calcium phosphate

hydroxyapatite (PCHA), is of low crystalline order with a

The end product, poorly crystalline

material.

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similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Intended Use: CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Materials: Synthetic calcium phosphate, sodium carboxymethyl cellulose, sodium bicarbonate, and sodium carbonate.

Performance Data: Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

ETEX Corp. c/o Christopher Klaczyk 38 Sidney Street Cambridge, Massachusetts 02139

FEB 1 8 2010

Re: K093447

Trade/Device Name: CarriGen Porous Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: January 15, 2010 Received: January 19, 2010

Dear Mr. Klaczyk:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Klaczyk

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807:97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Laurence V. Berger

ACTING
DSORD DIRECTOR

For Mark N. Melkerson · Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Special 510(k) Submission - CarriGen (OssiPro) Modification

## 4. Indications For Use

510(k) Number (if known):

Device Name:

CarriGen® Porous Bone Substitute Material (originally cleared as OssiPro)

Indications for Use:

CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Sign-Off) Division of Surgical Orthopedic. and Restorative Devices

510(k) Number K093447

ETEX Corporation

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