VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL

K032288 · Orthovita, Inc. · MQV · Dec 19, 2003 · Orthopedic

Device Facts

• Record ID: K032288
• Device Name: VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skelctal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Device Story

Porous calcium phosphate resorbable material admixed with Type I bovine collagen; trabecular structure mimics human cancellous bone; pore diameters 1-1000 um. Implanted by surgeons in OR/clinic to fill bony voids/gaps in extremities, spine, and pelvis. May be mixed with autogenous blood or bone marrow prior to placement. Osteoconductive scaffold guides 3D bone regeneration; resorbs concurrently with new bone ingrowth and remodeling. Does not provide mechanical stability. Benefits patient by facilitating natural bone repair in non-load-bearing defects.

Clinical Evidence

No clinical data. Pre-clinical animal data demonstrated scaffold supports bone growth into metaphyseal defects and resorbs concurrently with bone remodeling. In-vitro data supports safety and effectiveness equivalence to predicates.

Technological Characteristics

Material: Beta-tricalcium phosphate (Ca3(PO4)2) and Type I bovine collagen. Structure: Trabecular, porous (1-1000 um). Form: Sterile cylinders or strips. Energy: None. Connectivity: None. Sterilization: Gamma irradiation. Mechanical: Non-load bearing.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis). Contraindicated for large defects that would not heal spontaneously or defects intrinsic to bony 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 Synthetic Cancellous Bone Void Filler
• Healos® Bone Graft Material

Submission Summary (Full Text)

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# 510(k) Summary Vitoss® Scaffold Foam Bone Graft Material

| Submitted by | Address | Telephone | Contact Person |
|---------------------|----------------------------------------------|----------------|-------------------------------------------------------------------------------------------|
| Orthovita, Inc. | 45 Great Valley Parkway<br>Malvern, PA 19355 | [phone] | Gina M. Nagvajara, Ph.D.<br>Director of Research and<br>Intellectual Property |
| | Subject Device | | Predicate Devices |
| Trade Name | Vitoss® Scaffold Foam<br>Bone Graft Material | | Vitoss® Scaffold Synthetic<br>Cancellous Bone Void Filler;<br>Healos® Bone Graft Material |
| Common Name | Bone Void Filler | | Bone Void Filler |
| Classification Name | Filler, Calcium Sulfate<br>Preformed Pellets | | Filler, Calcium Sulfate<br>Preformed Pellets |

#### Device Description:

DEC 1 9 2003

Vitoss Scaffold Foam is a porous calcium phosphate resorbable material admixed with Type I bovine collagen for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in both cylinder and strip forms. Vitoss Scaffold Foam may be mixed with autogenous blood or bone marrow.

Vitoss Scaffold Foam guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold Foam is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

## Intended Use:

Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skelctal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

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510(k) Summary Vitoss Foam Orthovita, Inc.

## Comparison to Predicate:

| | NEW DEVICE:<br>VITOSS SCAFFOLD<br>FOAM | PREDICATE:<br>VITOSS SCAFFOLD<br>SYNTHETIC | PREDICATE:<br>HEALOS BONE<br>GRAFT MATERIAL |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Bone Void Filler | Bone Void Filler | Bone Void Filler |
| Target Population | Individuals with bony<br>defects resulting from<br>surgery or trauma | Individuals with bony<br>defects resulting from<br>surgery or trauma | Individuals with bony<br>defects resulting from<br>surgery or trauma |
| Anatomical Locations | Bony voids or gaps of<br>the skeletal system, i.e.,<br>the extremities, spine<br>and pelvis | Bony voids or gaps of<br>the skeletal system, i.e.,<br>the extremities, spine<br>and pelvis | Bony voids or gaps of<br>the skeletal system, i.e.,<br>the extremities, spine<br>and pelvis |
| Labeling | Vitoss Scaffold Foam's product label contains the same intended use,<br>contraindications, warnings, precautions, and adverse events as for the Vitoss<br>Scaffold Synthetic Cancellous Bone Void Filler with the addition of collagen<br>related contraindications and adverse events from the Healos Bone Graft<br>Material product label; wording is not identical but is substantially equivalent | | |
| Materials | | | |
| Chemical<br>Composition | Calcium salt with Type<br>I bovine collagen | Calcium salt | Calcium salt with Type I<br>bovine collagen |
| Mineral Phase(s) | $β$ -Tricalcium phosphate<br>$Ca_3(PO_4)_2$ | $β$ -Tricalcium phosphate<br>$Ca_3(PO_4)_2$ | Hydroxyapatite<br>$Ca_{10}(PO_4)_6(OH)_2$ |
| Design | | | |
| Physical<br>Structure | Trabecular structure<br>similar to cancellous<br>bone | Trabecular structure<br>similar to cancellous<br>bone | Three dimensional,<br>open-cell matrix |
| Pore Size (range) | 1-1000 μm | 1-1000 μm | 4-200 μm |
| Performance | | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive |
| Mechanical<br>Strength | Does not impart<br>mechanical strength to<br>surgical site | Does not impart<br>mechanical strength to<br>surgical site | Does not impart<br>mechanical strength to<br>surgical site |
| Sterility | Sterilized by gamma<br>irradiation, single use<br>only | Sterilized by gamma<br>irradiation, single use<br>only | Sterilized by e-beam,<br>single use only |
| Biocompatibility | Established | Established | Established |
| Dosage Form(s) | Cylinders (Blocks),<br>Strips | Blocks, Morsels | Strips, Pads |

#### Non-clinical Performance Data:

Pre-clinical animal data demonstrate that Vitoss Scaffold Foam supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold Foam is resorbed concurrently with bone ingrowth and remodeling. These results, in conjunction with in-vitro data, demonstrate that Vitoss Scaffold Foam is as safe and as effective as the predicate devices, Vitoss Scaffold Synthetic Cancellous Bone Void Filler and Healos Bonc Graft Material.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Gina M. Nagvajara, Ph.D. Director of Research and Intellectual Property Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K032288

K032206 Regulation Number: 21 CFR 888.3045 Regulation Name: Bone void filler Regulatory Class: II Product Code: MQV Dated: December 1, 2003 Received: December 2, 2003

Dear Dr. Nagvajara:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to commerce province to may 20, 1978, the excordance with the provisions of the Federal Food. Ding, devices that have tocer rechassined in avere approval of a premarket approval application (PMA). and Cosmette Act (11ct) market the device, subject to the general controls provisions of the Act. The 1 the may, therefore, thans of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is enabilional controls. Existing major regulations affecting your device can may be sunyeet to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the councements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I has be advised that I Dr o waters at your device complics with other requirements of the Act that 1177 hab intatutes and regulations administered by other Federal agencies. You must of any i-cutcal statutes and regaraments, including, but not limited to: registration and listing (21 Comply with an the Hot 3 requirements)); good manufacturing practice requirements as set Of It fart 6077, abounting (21 CFR Part 820); and if applicable, the electronic Routh m the quants (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Mr. Lewis Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and wyourse FDA finding of substantial equivalence of your device to a legally premance notification 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 in you attire 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millican

Celia M. Witten, PhD, MD 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): K032288

Device Name: Vitoss® Scaffold Foam Bone Graft Material

#### Indications For Use:

Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is 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)

for Mark N Milker

Division of General, Restorative
and Neurological Devices

K032288