INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS

K063124 · Integra Lifesciences Corp. · MQV · Jan 19, 2007 · Orthopedic

Device Facts

• Record ID: K063124
• Device Name: INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
• Applicant: Integra Lifesciences Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Integra MOZAIK Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.

Device Story

Integra MOZAIK Osteoconductive Scaffold - Strip is a resorbable bone void filler; composed of porous, highly purified collagen matrix with dispersed high-purity beta-tricalcium phosphate (TCP) granules. Device features 3D trabecular pore structure mimicking human cancellous bone; designed to imbibe fluids (bone marrow aspirate or blood) for application. Implanted by surgeons into skeletal voids/gaps in extremities, spine, or pelvis; acts as osteoconductive scaffold guiding bone regeneration across defect sites. Matrix resorbs and is replaced by host bone during healing. Provides no mechanical strength to surgical site. Supplied sterile for single-use.

Clinical Evidence

Bench testing and animal study data provided. Animal study demonstrated support for bone growth and subsequent resorption/replacement by remodeled bone. In vitro product characterization, performance testing, and biocompatibility data support safety and effectiveness.

Technological Characteristics

Resorbable scaffold; Type I bovine collagen matrix with beta-tricalcium phosphate (ASTM F1088). Trabecular pore structure (12-350 microns). Non-load bearing. Sterilized via 100% ethylene oxide gas. Single-use.

Indications for Use

Indicated for patients with bony defects in extremities, spine, or pelvis resulting from surgery or trauma. Not for use in defects intrinsic to bony structure 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

• VITOSS® Scaffold Foam Bone Graft Matrix (K032288)

Submission Summary (Full Text)

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K063124

## 510(K) SUMMARY

## Integra MOZAIK™ Osteoconductive Scaffold

#### Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

JAN | 9 2007

## Contact person and telephone number:

Diana Bordon Manager, Regulatory Affairs Telephone: [phone] [phone] Fax:

## Date Summary was prepared:

December 11, 2006

#### Name of the device:

| Proprietary Name: | Integra MOZAIK™ Osteoconductive Scaffold – Strip |
|----------------------|--------------------------------------------------|
| Common Name: | Bone Void Filler |
| Classification Name: | Filler, Bone Void, Calcium Compound |
| Product Code: | MQV |

## Substantial Equivalence:

Integra MOZAIK Osteoconductive Scaffold - Strip is substantially equivalent in function and intended use to VITOSS® Scaffold Foam Bone Graft Matrix which has been cleared to market under Premarket Notification 510(k) K032288.

#### Device Description:

The Integra MOZAIK™ Osteoconductive Scaffold – Strip is a resorbable bone void filler made from a porous highly purified collagen matrix that high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.

The Integra MOZAIK Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure of the Integra MOZAIK Strip quickly imbibes fluids, making it easy to mx with bone marrow aspirate or blood.

Integra MOZAIK Strip guides the regeneration of bone across a critical defect site into which the strip is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

#### Intended Use:

The Integra MOZAIK Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip is resorbed and replaced with bone during the healing process.

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## Performance Data:

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Integra MOZAIK Strip has been demonstrated to support bone growth in an animal study, where it was ultimately resorbed and replaced by remodeled bone. These results, in conjunction with in vitro product characterization studies, performance testing and biocompatibility data demonstrate that Integra MOZAIK Osteoconductive Scaffold -Strip is as safe and effective as its predicate device.

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| Feature | Integra MOZAIK™<br>Osteoconductive Scaffold - Strip | VITOSS® Foam Strip<br>Bone Graft Material |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Integra LifeSciences Corp. | Orthovita, Inc., Malvern, PA |
| 510(k) | K063124 | K032288 |
| Classification | MQV | MQV |
| Indications for Use | Integra MOZAIK™ Osteoconductive<br>Scaffold - Strip is intended for use as<br>a bone void filler to fill voids or gaps<br>of the skeletal system in the<br>extremities, spine, and pelvis not<br>intrinsic to the stability of the bony<br>structure. Integra MOZAIK Strip is<br>also indicated for use in the treatment<br>of surgically treated osseous defects<br>or osseous defects created from<br>traumatic injury to the bone.<br>Following placement in the bony<br>void or gap (defect), Integra<br>MOZAIK is resorbed and replaced<br>with bone during the healing process. | VITOSS Scaffold Foam Bone Graft<br>Material is intended for use as a bone<br>void filler for voids or gaps that are not<br>intrinsic to the stability of the bony<br>structure. VITOSS Scaffold Foam is<br>indicated for use in the treatment of<br>surgically created osseous defects or<br>osseous defects created from traumatic<br>injury to the bone. VITOSS Scaffold<br>Foam should not be used to treat large<br>defects that in the surgeon's opinion<br>would fail to heal spontaneously.<br>VITOSS Scaffold Foam Bone Graft<br>Material is intended to be used for filling<br>bony voids or gaps of the skeletal system<br>(i.e., the extremities, spine and pelvis).<br>Following placement in the bony void or<br>gap, the scaffold resorbs and is replaced<br>with bone during the healing process. |
| Target population | Individuals with bony defects<br>resulting from surgery or trauma | Individuals with bony defects resulting<br>from surgery or trauma |
| Design | | |
| • Physical structure | Trabecular structure similar to<br>cancellous bone in strip form. | Trabecular structure similar to<br>cancellous bone in strips, cylinder and<br>shape forms. |
| • Pore Structure<br>(range) | 12 - 350 microns | 12 - 700 microns |
| Materials | | |
| • Chemical<br>composition | Calcium salt with Type I bovine<br>collagen | Calcium salt with Type I bovine<br>collagen |
| • Mineral Phase | β-Tricalcium phosphate Ca3(PO4)2<br>per ASTM F1088 | β-Tricalcium phosphate Ca3(PO4)2<br>per ASTM F1088 |
| Performance | | |
| • Osteoconductivity | Osteoconductive | Osteoconductive |
| • Mechanical<br>Strength | Does not impart mechanical strength<br>to surgical site | Does not impart mechanical strength to<br>surgical site |
| Sterility | Sterilized by 100% ethylene oxide<br>gas, single use only | Sterilized by gamma irradiation, single<br>use only |
| Biocompatibility | Biocompatible | Biocompatible |
| Anatomical location | Bony voids or gaps of the skeletal<br>system i.e. the extremities, spine and<br>pelvis | Bony voids or gaps of the skeletal<br>system i.e. the extremities, spine and<br>pelvis |
| Dosage Form(s) | 15 cc (25 x 100 x 6mm) | 25 x 50 x 4mm (5cc)<br>25 x 100 x 8mm (20cc)<br>25 x 100 x 4mm (10cc)<br>75 x 100 x 4mm (30cc) |

## Substantial Equivalence Comparison Chart

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra LifeSciences Corporation % Ms. Diana Bordon Manager, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

JAN 1 9 2007

Re: K063124

Trade/Device Name: MOZAIK™ Osteoconductive Scaffold - Strips -Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 12, 2006 Received: December 14, 2006

Dear Ms. Bordon:

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. Diana Bordon

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,

barbara Bruckm

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

510(k) Number (if known):

Device Name: Integra MOZAIK™ Osteoconductive Scaffold - Strip

Indications For Use: The Integra MOZAIK Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Strip 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buehrig for mxm
(Division Sign-off)

Division of General, Restorative, and Neurological Devices

510(k) Number K063124

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