OSSIMEND (TM) BONE GRAFT MATERIAL

K052812 · Collagen Matrix, Inc. · MQV · Jan 25, 2006 · Orthopedic

Device Facts

• Record ID: K052812
• Device Name: OSSIMEND (TM) BONE GRAFT MATERIAL
• Applicant: Collagen Matrix, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jan 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) 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.

Device Story

OssiMend is a collagen-mineral composite bone void filler; composed of 55% anorganic bovine bone mineral and 45% bovine type I collagen. Provided as sterile, dry strips, pads, or granules; hydrated with autogenous bone marrow by the surgeon at the point of care. Implanted into non-structural bony defects in extremities, spine, or pelvis. Acts as a scaffold for natural bone formation and remodeling; fully resorbed over time. Designed to retain physical integrity and shape post-implantation. Used by surgeons to fill osseous voids; aids in bone repair and regeneration.

Clinical Evidence

No human clinical data provided. Evidence consists of in vitro product characterization, in vitro and in vivo biocompatibility testing (passing ISO 10993-1/FDA G95-1 standards), and an animal study confirming effectiveness as a bone void filler.

Technological Characteristics

Composite matrix of 55% anorganic bovine bone mineral and 45% bovine type I collagen. Three-dimensional open porous structure. Provided sterile and dry; hydrated with autogenous bone marrow. Resorbable. Form factors: strips, pads, or granules.

Indications for Use

Indicated for filling non-structural bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgical procedures or traumatic injury. Requires combination with autogenous bone marrow. Prescription use only.

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

• HEALOS® Bone Graft Material (K012751)
• CopiOs™ Bone Void Filler (K033679)
• Collagraft Strip Bone Graft Matrix (K000122)
• Vitoss® Scaffold Foam Bone Graft Material (K032288)
• ORTHOSS™ Resorbable Bone Void Filler (K014289)
• OsteoGuide® Anorganic Bone Mineral Products (K043034)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

JAN 2 5 2006

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | December 21, 2005 |
| Device Common Name: | Bone Grafting Material<br>Bone Void Filler |
| Device Trade Name: | OssiMend™ Bone Graft Material |
| Device Classification Name:<br>Regulation Number:<br>Device Class:<br>Product Code: | Filler, Bone Void, Calcium Compound<br>888.3045<br>Class II<br>MQV |
| Predicate Device(s): | HEALOS® Bone Graft Material, K012751<br>CopiOs™ Bone Void Filler, K033679<br>Collagraft Strip Bone Graft Matrix, K000122<br>Vitoss® Scaffold Foam Bone Graft Material, K032288<br>ORTHOSS™ Resorbable Bone Void Filler, K014289<br>OsteoGuide® Anorganic Bone Mineral Products, K043034 |

#### Description of the Device

OssiMend™ Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation. The principle components of OssiMend are bovine type I collagen and anorganic bovine bone mieral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. OssiMend is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. OssiMend strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. OssiMend is fully resorbed during the natural process of bone formation and remodeling.

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#### Intended Use

OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) 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.

#### Summary/Comparison of Technical Characteristics

OssiMend and its predicates have the same technological characteristics. In particular, OssiMend and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

### Safety

OssiMend has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

### Effectiveness

The characteristics of the OssiMend meet the design requirements for an effective bone grafting material, and an animal study confirmed the effectiveness of the product for use as a bone void filler.

#### Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates.

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Public Health Service

JAN 2 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K052812/S1

Trade/Device Name: OssiMend™ Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: December 22, 2005 Received: December 23, 2005

Dear Ms. Hansen:

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. Peggy Hansen, RAC

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

Acting 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

510(k) Number (if known): _ KO52812___________________________________________________________________________________________________________________________________________

Device Name: _ OssiMend TM Bone Graft Material

Indications for Use:

OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that arr 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 hone.

Prescription Use X (Part 21 CFR 801 Subpart D)

:

______________________________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number K052812