COLLOSS E BONE VOID FILLER

K051047 · Ossacur AG · MQV · Mar 8, 2006 · Orthopedic

Device Facts

• Record ID: K051047
• Device Name: COLLOSS E BONE VOID FILLER
• Applicant: Ossacur AG
• Product Code: MQV · Orthopedic
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.

Device Story

COLLOSS E is a resorbable bone void filler derived from equine diaphyseal bone; consists of Type I collagen matrix and insoluble proteins. Supplied as a dry, cotton-like lyophilizate in 20 mg vials. Intended for surgical use by physicians to fill non-structural osseous defects in the spine, pelvis, ilium, or extremities. Device is implanted into the void; resorbs over time and is replaced by natural bone during the healing process. Provides a scaffold for bone regeneration.

Clinical Evidence

No clinical data provided. Evidence consists of bench characterization per ASTM F 2212-02 and animal testing results demonstrating suitability for use as a bone void filler.

Technological Characteristics

Material: Extracellular matrix from equine diaphyseal bone (Type I collagen and insoluble proteins). Form: Lyophilized, cotton-like matrix. Sterilization: Plasma sterilization of inner pouch surfaces. Characterization: Compliant with ASTM F 2212-02 (Standard Guide for Characterization of Type I Collagen).

Indications for Use

Indicated for filling non-structural bony voids or gaps in the skeletal system, including spine, pelvis, ilium, and extremities, caused by surgical procedures, trauma, or degenerative processes.

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

• OSSAPLAST TM ORTHO Bone Void Filler (K042305/K050416)
• HEALOS® II Bone Graft Substitute (K012751/K043308)
• Osteofil® DBM (K043420/K043421)
• InterGro® DBM (K031399)

Submission Summary (Full Text)

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2006 MAR 8

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# 510(K) Summary

- A. Submitter Information

| Submitter's Name: | OSSACUR® AG |
|----------------------|---------------------------------------------------|
| Address: | Benzstrasse 2<br>D-71720<br>Oberstenfeld, Germany |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| Contact Person: | Arne Briest |
| Date of Preparation: | April 21, 2005 |

- B. Device Name

| Trade Name: | COLLOSS™ E |
|----------------------|-------------------------------------------------|
| Common/Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| | §888.3045 (Product Code: MQV) |

- C. Predicate Devices

| Trade Name: | OSSAPLAST TM ORTHO Bone Void Filler<br>(K042305/K050416) |
|-------------|----------------------------------------------------------------------|
| Trade Name: | HEALOS® II Bone Graft Substitute<br>(K012751/K043308) |
| Trade Name: | Osteofil® DBM (K043420/K043421) |
| Trade Name: | InterGro® DBM (K031399) |

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#### D. Device Description

COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present.

COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.

#### E. Intended Use

COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.

#### F. Technological Characteristics Summary

COLLOSS E was characterized in accordance with ASTM F 2212-02: Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPS). The product description information and characterization data in conjunction with the device labeling demonstrate substantial equivalence to the predicate devices.

#### G. Performance Data

No performance standards have been established for this type of device. The results of animal testing demonstrated that COLLOSS E is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2006

OSSACUR AG c/o Pacific OtterWorks, Inc. Ms. Kristi Kistner, RAC President 975 Veronica Springs Road Santa Barbara, California 93105

Re: K051047/S1

Trade/Device Name: COLLOSS™ E 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: September 16, 2005 Received: September 19, 2005

Dear Ms. Kistner:

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. Isting 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. Tixisting major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. I 1 ) V may publish further announcements concerning your device in the Federal Register

Please be advised that FDA is issuance of a substantial equivalence determination does no 1000 that FDA has made a determination that your device complies with other requirements of the he 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

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Page 2 - Ms. Kistner

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,

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 (TFR 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,

Herbert Lewin

Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION I-E.

### Statement of Indications for Use

510(k) Number (if known):

Device Name: COLLOSS™ E Bone Void Filler

Indications for Use:

COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hele Luvin is

Division Sign-Off)

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Division of General, Restorative, and Neurological Devices

510(k) Number K051047

OSSACUR® AG

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