VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

K032409 · Orthovita, Inc. · MQV · Aug 29, 2003 · Orthopedic

Device Facts

• Record ID: K032409
• Device Name: VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vitoss Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Story

Vitoss Scaffold is a porous, resorbable calcium phosphate bone void filler; trabecular structure mimics human cancellous bone. Implanted by surgeons into bony voids or gaps in extremities, spine, or pelvis; may be combined with autogenous blood or bone marrow. Device acts as an osteoconductive scaffold; guides 3D bone regeneration as host bone grows into the implant surface. Implant resorbs over time, replaced by new bone and connective tissue. Intended for non-structural defects; does not provide mechanical strength to the surgical site.

Clinical Evidence

No clinical data provided. Evidence based on animal studies demonstrating 80% resorption of the scaffold within twelve weeks and established biocompatibility.

Technological Characteristics

Material: β-Tricalcium Phosphate (Ca3(PO4)2) compliant with ASTM F 1088. Structure: Porous trabecular scaffold with 90% porosity and 1-1000μm pore size. Form factor: Blocks and morsels. Sterilization: Gamma radiation. Non-mechanical, non-electronic.

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 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

• WMT-TCP (K022629)
• chronOS (K013072)

Submission Summary (Full Text)

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K032409

## 510(k) Summary Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

| Submitted by | Address | Telephone | Contact Person |
|---------------------|-------------------------------------------------------------|----------------|---------------------------------------------------|
| Orthovita, Inc. | 45 Great Valley Parkway<br>Malvern, PA 19355 | [phone] | Andreina Ide, Sr. Director,<br>Regulatory Affairs |
| | | Subject Device | Predicate Devices |
| Trade Name | Vitoss® Scaffold Synthetic<br>Cancellous Bone Void Filler | | WMT-TCP K022629 chronOS K013072 |
| Common Name | Resorbable Synthetic Bone Void Filler/Bone Graft Substitute | | |
| Classification Name | Resorbable Calcium Salt Bone Void Filler Device | | |

### Device Description:

Vitoss Scaffold is a porous calcium phosphate resorbable bone void filler 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 block and morsel forms.

Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.

### Intended Use:

Vitoss Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood

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and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

| | Vitoss Scaffold | WMT-TCP | ChronOS |
|-----------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | Resorbable Synthetic Bone Void Filler | Resorbable Synthetic Bone Void Filler | Resorbable Synthetic Bone Void Filler |
| Target Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma |
| Anatomical Locations | Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis | Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis | Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis |
| Labeling | Labeling contains same intended use as predicate devices | Labeling contains same intended use as Vitoss Scaffold | Labeling contains same intended use as Vitoss Scaffold |
| Materials | β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088 | Tricalcium Phosphate – satisfies ASTM F 1088 | β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088 |
| Design | | | |
| • Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone | Uniform, three-dimensional pore structure |
| • Porosity | Approximately 90% | Reported as “highly porous” | Approximately 60% to 70% |
| • Pore Size (range) | 1-1000μm | | 100-500μm |
| Performance | | | |
| • Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive |
| • Resorption | Demonstrated as 80% resorbed at twelve weeks | Reported as “resorbable” | Resorption reported to occur between 6 and 12 months. |
| • Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site |
| Sterility | Sterilized by gamma radiation, single use only | Sterilized by gamma radiation, single use only | Sterilized by gamma radiation, single use only |
| Biocompatibility | Established | Established | Established |
| Dosage Form(s) | Morsels and Blocks | Granules and Blocks | Granules, Cylinders and Blocks |

## Comparison to Predicate:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Ms. Andreina Ide Sr. Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Re: K032409

Trade Name: Vitoss Scaffold Synthetic Cancellous Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 1, 2003 Received: August 4, 2003

Dear Ms. Ide:

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. Andreina Ide

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/dsma/dsmamain.html

Sincerely yours,

Mark N. Milken

Celia M. Witten, Ph.D., M.D. 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: K032409

Device Name: Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

## Indications For Use:

(Per 21 CFR 801.109)

Vitoss Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

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for
Concurrence of CDRH Office of Device Evaluation (ODE)
(
On Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K032409
Prescription Use OR Over-The-Counter Use