NANOSS BONE VOID FILLER

K100361 · Pioneer Surgical Technology · MQV · Apr 22, 2010 · Orthopedic

Device Facts

• Record ID: K100361
• Device Name: NANOSS BONE VOID FILLER
• Applicant: Pioneer Surgical Technology
• Product Code: MQV · Orthopedic
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pioneer Surgical NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Story

NanOss™ BVF-E is a resorbable bone void filler composed of calcium phosphate in a porcine gelatin carrier. Provided in granular form, it is mixed with saline or blood at the time of implantation to facilitate reconstitution. The device is packed into non-structural bony voids or gaps in the extremities or pelvis. It acts as a scaffold that resorbs over time, allowing for replacement by new bone growth during the healing process. The device is radiopaque, sterile, and intended for single use by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable bone void filler; calcium phosphate in porcine gelatin carrier; granular form; radiopaque; sterile; single-use.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic bone injuries in the skeletal system (extremities, pelvis) requiring a bone void filler for gaps not intrinsic to bony stability.

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

• NanOss™ BVF-E (unmodified version)

Submission Summary (Full Text)

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NanOss™ BVF-E

K1000361

APR 2 2 2010

# 510(k) Summary

Pioneer Surgical Technology Special 510(k): Device Modification

## NanOss™ BVF-E

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 Telephone: [phone] [phone] Fax:

Official Contact:

Representative/Consultant:

Jonathan Gilbert

David J. Collette or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

NanOss™ BVF-E Bone Void Filler Filler, Bone Void, Calcium Compound 21 CFR 880.3045. Class II MOV Orthopaedic and Rehabilitation Devices Restorative Devices Branch

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#### INTENDED USE

Pioneer Surgical NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

### DEVICE DESCRIPTION

NanOss BVF-E is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. This submission introduces a packaging modification intended to facilitate reconstitution of the device by mixing with saline or blood at the time of implantation.

NanOss BVF-E is radiopaque, provided sterile and is intended for single use only.

### EQUIVALENCE TO MARKETED PRODUCT

The modified NanOss BVF-E has the following similarities to the unmodified NanOss BVF-E: has the same intended use,

uses the same operating principle, incorporates the same basic design, incorporates the same materials, and is provided sterile.

In summary, the NanOss BVF-E, described in this submission is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pioneer Surgical Technology % Paxmed International, LLC David J. Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K100361

APR 2 2 2010

Trade/Device Name: NanOss™ BVF-E Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 30, 2010 Received: March 31, 2010

Dear Dr. Collette:

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 udications 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, Dr te 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and 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 devire 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 - David J. Collette, M.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf DA/CentersOffices/CDRH/CDRHOffices/ucm1158091jy priou 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barbara Buelum

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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# Indications for Use

510(k) Number: K100361

NanOss™ BVF-E

Indications for Use

Device Name:

NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Prescription Use XX Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Barry

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510(k) Number K100361

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