OSTEOCRETE BONE VOID FILLER

K071004 · Bone Solutions, Inc. · MQV · May 21, 2009 · Orthopedic

Device Facts

• Record ID: K071004
• Device Name: OSTEOCRETE BONE VOID FILLER
• Applicant: Bone Solutions, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: May 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Device Story

OsteoCrete™ is an injectable, moldable bone void filler; consists of magnesium-based powder and buffered saline mixing solution. Used by surgeons to fill bony voids or gaps in long bones and pelvis; defects may be traumatic or surgically created. Device resorbs over time and is replaced by natural bone during healing. Not for use in defects requiring structural stability or large defects unlikely to heal spontaneously. Supplied as a sterile, single-use kit with mixing and administration tools.

Clinical Evidence

Bench and animal performance testing conducted per FDA guidance. No clinical data presented.

Technological Characteristics

Magnesium-based powder and buffered saline mixing solution. Injectable, moldable, resorbable bone void filler. Sterile, single-use device.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the long bones and pelvis that are not intrinsic to skeletal stability. Not indicated for large defects unlikely to 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

• Norian SRS Bone Void Filler (K011897)
• Norian SRS Fast Set Putty (K041842)
• OsteoCure Resorbable Bead Kit (K051406)
• Cerament Bone Void Filler (K051951)

Submission Summary (Full Text)

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## 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

| Submitted by: | Bone Solutions, Inc.<br>9400 N. Central Expressway, Suite 1250, L.B.103<br>Dallas, TX 75231 USA<br>Phone: [phone]<br>Tony Copp, Ph.D., COO<br>email: [e-mail]<br>Fax: [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person for premarket notification:<br>Christine Emanuel, Regulatory Consultant<br>1205 De La Vina Street<br>Santa Barbara, CA 93101<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | May 4, 2009 |
| Proprietary Name: | OsteoCrete™ Bone Void Filler |
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Class II, MQV, 21 CFR 888.3045 |
| Predicate Devices: | Synthes (USA). Norian SRS Bone Void Filler, 510(k) number<br>K011897<br>Synthes (USA). Norian SRS Fast Set Putty, 510(k) number<br>K041842<br>Futura Biomedical. OsteoCure Resorbable Bead Kit, 510(k)<br>number K051406<br>Bone Support AB. Cerament Bone Void Filler, 510(k)<br>number K051951 |
| Device Description: | OsteoCrete™ is an injectable, moldable, and biocompatible<br>Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet<br>contains powder (Magnesium based compound) and a mixing<br>solution (Buffered saline). It is a sterile, single use device,<br>packaged with mixing and administration tools. |
| Indication for Use: | Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is<br>intended only for bony voids or defects that are not intrinsic to |

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OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bones and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA." The testing confirmed substantial equivalence to the predicate device.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bone Solutions Incorporated % Mr. Tony Copp Director, Executive Vice President, Chief Operating Officer 9400 North Central Expressway, Suite 1250 Dallas, Texas 75231

MAY 2 1 2009

Re: K071004

Trade/Device Name: OsteoCrete™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 26, 2008 Received: August 28, 2008

Dear Mr. Copp:

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 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); 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.

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Page 2- Mr. Tony Copp

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,
Mark A. Milliken

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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Request for additional information from the FDA to Bone Solutions regarding K071004.

## Indications for Use

510(k) Number (if known): K071004

Device Name: Bone Solutions, Inc. OsteoCrete™ Bone Void Filler

Indications for Use:

Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

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)

Mark A. Millman

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

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