COPIOS BONE VOID FILLER SPONGE AND PASTE

K071237 · Kensey Nash Corp. · MQV · Jun 1, 2007 · Orthopedic

Device Facts

• Record ID: K071237
• Device Name: COPIOS BONE VOID FILLER SPONGE AND PASTE
• Applicant: Kensey Nash Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

Device Story

CopiOs™ Bone Void Filler is a resorbable bone graft substitute consisting of calcium phosphate and Type I bovine dermal collagen. The device is provided as a compressed powder disc (Paste) or sponge. The Paste form is prepared by the surgeon by mixing the powder disc with autologous blood products (e.g., bone marrow) using a supplied spatula. The resulting mixture is manually packed into non-structural bone voids or gaps in the extremities, pelvis, or spine. The device acts as a scaffold that resorbs during the natural bone healing process. It is intended for use by surgeons in clinical settings to assist in filling voids created by trauma or surgical procedures. The device provides a physical filler that supports the healing environment without providing structural stability to the bone.

Clinical Evidence

Bench testing only. Testing included biocompatibility, migration resistance, pH, hydration, and handling characteristics to demonstrate safety and performance equivalence to the predicate device.

Technological Characteristics

Resorbable bone void filler composed of calcium phosphate and Type I bovine dermal collagen. Supplied as compressed powder discs or sponges. Gamma-sterilized for single use. Available in 1cc, 5cc, and 10cc volumes. Manual mixing with autologous blood products required for paste form.

Indications for Use

Indicated for filling non-structural bone voids or gaps in the skeletal system (extremities, pelvis, spine) resulting from trauma or surgery in patients requiring bone void filling, used in combination with autologous blood products.

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

• CopiOs™ Bone Void Filler (Sponge) (K033679)

Submission Summary (Full Text)

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KO71237

2007

# 510(k) Summary

| Submitted by: | Kensey Nash Corporation<br>735 Pennsylvania Drive<br>Exton, PA 19341 | JUN - 1 |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Jennifer J. Bosley, MBA, RAC<br>Regulatory Affairs Specialist<br>Ph: [phone]<br>Fax: [phone] | |
| Date Prepared: | May 2, 2007 | |
| Device Trade Name:<br>Common/Usual Name:<br>Proposed Classification: | CopiOs™ Bone Void Filler<br>Bone Void Filler<br>Resorbable Calcium Salt Bone Void Filler Device<br>21CFR § 888.3045<br>Class II MOV-87Orthopedics | |

## Device Description:

CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.

## Intended Use:

CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

## Predicate Device:

K033679-CopiOs™ Bone Void Filler (Sponge), Kensey Nash Corp [Centerpulse Spine-Tech]

## Substantial Equivalence:

CopiOs™ Paste is substantially equivalent to the legally marketed predicate device, CopiOs™ Sponge with regard to materials, processing, intended use and fundamental scientific technology.

## Non-Clinical Testing:

CopiOs™ Paste has undergone non-clinical testing, including biocompatibility, migration resistance, pH, hydration and handling characteristics. Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device.

1-484-713-2100

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN - 1 2007

Re: K071237

Trade/Device Name: CopiOs™ 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: May 2, 2007 Received: May3, 2007

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 J. 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 [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/industry/support/index.html.

> Sincerely yours, Mark N. Melkerson 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

510(k) Number (if known):

Device Name:

CopiOs™ Bone Void Filler

#### Indications For Use:

CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.

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

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)

Division of General, Restorative, and Neurological Devices

**510(k) Number** 16011237

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