VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE

K081439 · Orthovita, Inc. · MQV · Jun 17, 2008 · Orthopedic

Device Facts

• Record ID: K081439
• Device Name: VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss® Bioactive Foam Bone Graft Substitute 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.

Device Story

Resorbable, osteoconductive bone graft substitute; trabecular structure mimics human cancellous bone. Implanted by surgeons into bony voids or gaps in extremities, spine, or pelvis. Scaffold resorbs over time, replaced by natural bone during healing. Osteostimulatory properties demonstrated in vitro via calcium phosphate growth in simulated body fluid. Device serves as a void filler; not intended for structural support.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vitro studies demonstrating osteostimulatory properties (calcium phosphate growth in simulated body fluid) compared to non-bioactive controls.

Technological Characteristics

Resorbable, osteoconductive implant; trabecular structure with multidirectional interconnected porosity. Material composition includes bioactive glass. Form factor: foam strip and pack. Sterilization method not specified.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) that are not intrinsic to bony stability. Contraindicated for large defects that would not heal spontaneously.

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 Bioactive Foam Bone Graft Substitute (K072184)

Submission Summary (Full Text)

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K081439

JUN 1 7 2008

Vitoss Bloactive Foam Pack Special 510(k) Notification Orthovita, Inc.

#### 510(k) SUMMARY

# VITOSS® BIOACTIVE FOAM and VITOSS® BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTES

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Phone: [phone]

Facsimile: [phone]

| Contact Person: | David J. McIlhenny |
|-----------------|----------------------|
| | Sr. V.P., Operations |

May 21, 2008 Date Prepared:

Common or Usual Name - Vitoss® Bone Graft Substitute- Bioactive Foam Pack, Vitoss® BA Pack Bone Graft Substitute, Bone Graft Substitute

Classification Name - Bone Void Filler

Product Code -MQV

#### Predicate Devices

Orthovita, Inc. - Vitoss Bioactive Foam Bone Graft Substitute (K072184)

## Intended Use / Indications for Use

Vitoss® Bioactive Foam Bone Graft Substitute- STRIP and PACK are labeled with the following Intended Use statement and are labeled with the following Indications for Use statement:

Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or

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osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss® Bioactive Foam Bone Graft Substitute 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.

#### Device Description

Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack are resorbable, osteoconductive implants with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

#### Performance Data

Performance testing was conducted to ensure that Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack met the predetermined design specifications. In all instances, Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack functioned as intended,

Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack are osteostimulatory based on invitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack after exposure to simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component. The osteostimulatory nature of Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack has not been correlated to human clinical experience.

#### Substantial Equivalence

Vitoss Bioactive Foam Pack, subject of the Special 510(k), is a product line extension to the Vitoss Bioactive Foam product line. Vitoss Bioactive Foam Pack has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor differences between Vitoss Bioactive Foam Pack and the predicate device raise no new issues of safety or effectiveness. Thus, Vitoss Bioactive Foam Pack is substantially equivalent to Vitoss Bioactive Foam.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and vigilance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Orthovita, Inc % Mr. David J. McIlhenny Senior Vice President Operations 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K081439

Trade/Device Name: Vitoss® Bioactive Foam Bone Graft Substitute-STRIP and PACK Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: May 21, 2008 Received: May 22, 2008

Dear Mr. Gilbert:

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 - Mr. Jonathan M. Gilbert

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

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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Vitoss Bioactive Foam Pack Special 510(k) Notification Orthovita, Inc.

510(k) Number (if known): KC31439

Device Name: Vitoss® Bioactive Foam Bone Graft Substitute- STRIP and PACK

Intended Use/Indications for Use:

Vitoss® Bioactive Foam Bone Graft Substitute 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 Bioactive Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss® Bioactive Foam Bone Graft Substitute 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Nilker Ogl fr man

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

510(k) Number K081439