KENSEY NASH BONE VOID FILLER

K060917 · Kensey Nash Corporation · MQV · Sep 22, 2006 · Orthopedic

Device Facts

• Record ID: K060917
• Device Name: KENSEY NASH BONE VOID FILLER
• Applicant: Kensey Nash Corporation
• Product Code: MQV · Orthopedic
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous blood products does not alter the performance of the device.

Device Story

Resorbable bone void filler composed of beta tricalcium phosphate, polylactic acid, and Type I bovine collagen. Provided as pre-formed cylinders, granules, cubes, or blocks. Intended for surgical use to fill non-structural bony voids in extremities and pelvis. Clinician packs material into defect; may be mixed with saline, blood, or bone marrow aspirate. Device resorbs over time, facilitating replacement with natural bone during healing. Gamma sterilized for single use.

Clinical Evidence

Non-clinical testing only. Included biocompatibility, physical properties, compressive strength, and animal study.

Technological Characteristics

Mixture of beta tricalcium phosphate, polylactic acid, and Type I bovine collagen. Resorbable calcium salt bone void filler. Provided in various shapes (cylinders, granules, cubes, blocks) up to 25 mm diameter and 30 cc volume. Gamma sterilized.

Indications for Use

Indicated for filling bony voids or gaps in extremities and pelvis caused by trauma or surgery that are not intrinsic to bony structure stability. Applicable to traumatic bone injuries or surgically created osseous defects. May be used with saline, blood, or bone marrow aspirate.

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

• PolyGraft™ BGS (K040047)
• PolyGraft™ TCP (K033707)
• CopiOs™ Bone Void Filler (K033679)
• MasterGraft® Putty (K051386)

Submission Summary (Full Text)

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K0600917

# 510(k) Summary

SEP 2 2 2006

Submitted by: Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341 Contact Person: Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist Ph: [phone] Fax: [phone] Date Prepared: September 14, 2006 510(k) #: K060917 Device Trade Name: Kensey Nash Bone Void Filler Common/Usual Name: Bone Void Filler Proposed Classification: Resorbable Calcium Salt Bone Void Filler Device 21CFR8888.3045 Class II, MQV-87Orthopedics

### Device Description:

Kensey Nash Bone Void Filler is a mixture of beta tricalcium phosphate, polylactic acid and Type I bovine collagen. The product will be provided gamma sterilized for one-time use in a variety of shapes ranging from pre-formed cylinders, granules, cubes and blocks with sizes ranging up to 25 mm in diameter and up to 30 cc in volume.

### Intended Use:

The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous blood products does not alter the performance of the device.

## Predicate Devices:

| MANUFACTURER | DEVICE | 510(k) # |
|--------------------------------------|--------------------------|----------|
| OsteoBiologics | PolyGraft™ BGS | K040047 |
| OsteoBiologics | PolyGraft™ TCP | K033707 |
| Kensey Nash [Centerpulse Spine-Tech] | CopiOs™ Bone Void Filler | K033679 |
| Medtronic | MasterGraft® Putty | K051386 |

# Substantial Equivalence:

Kensey Nash BVF is substantially equivalent to the legally marketed predicate devices with regard to intended use, materials, physical structure, principle of operation and technological characteristics. Results of in vivo and in viro comparison testing demonstrate that Kensey Nash BVF is substantially equivalent to PolyGrafi™ BGS.

### Non-Clinical Testing:

Kensey Nash BVF has undergone non-clinical testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing included biocompatibility, physical properties testing, compressive strength and an animal study.

#### 1-800-524-1984

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Kensey Nash Corporation % Ms. Jennifer J. Bosley Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K060917

Trade/Device Name: Kensey Nash Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 21, 2006 Received: August 22, 2006

Dear Ms. Bosley:

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. Jennifer Bosley

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 240-276-0120. 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 Houracturers; International and Consumer-Assistance at its toll-free-number (809)-638-2011 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Joulau Bucheno

Mark N. Melkerso 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 Statement

K060917 510(k) Number:

Kensey Nash Bone Void Filler Device Name:

## Indications For Use:

The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or - and gape of the extremities and pelvis that are caused by trauma or surgery-and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous products does not alter the performance of the device.

> Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (Per 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)

Barbara Burchum for mkm

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

510(k) Number K0140917

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