VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

K994337 · Orthovita Co. · MQV · Dec 14, 2000 · Orthopedic

Device Facts

• Record ID: K994337
• Device Name: VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
• Applicant: Orthovita Co.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K994337 · Dec 14, 2000	VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER	Orthovita Co.	FDA Manufacturer and User Facility Device Experience Database (MAUDE)	The sponsor performed a retrospective review of the MAUDE database to assess the safety profile of the predicate device (Pro Osteon 500R) and related calcium-based bone void fillers to support the safety argument for the subject device.	MAUDE database; Postmarket surveillance; Safety review

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
MAUDE Database Review; Retrospective database review; Follow-up/Duration: Not applicable; Study Period: Review conducted on 12/13/1999	Users of Pro Osteon 500R and other devices with product code MQV; Number of Sites: Not applicable	Not applicable for this study	Adverse device experiences

Indications for Use

Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only 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 gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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, osteoconductive synthetic bone void filler composed of beta-tricalcium phosphate. It features a trabecular structure mimicking human cancellous bone with approximately 90% porosity and pore sizes ranging from 1-1000 µm. Provided in block or morsel forms, the device is implanted by a surgeon into bony voids or gaps in the extremities, spine, or pelvis. The scaffold acts as a temporary matrix; as it resorbs, it facilitates the ingrowth of new host bone and connective tissue. It does not provide mechanical stability to the surgical site. The device is intended for single-use and is sterilized via gamma radiation.

Clinical Evidence

No clinical trials were conducted for this submission. Evidence relies on pre-clinical animal studies demonstrating bone ingrowth, remodeling, and resorption (80% resorbed at 12 weeks). Clinical safety is supported by 25+ years of literature on calcium-based ceramics in dentistry and orthopedics, and a review of the FDA MAUDE database showing no adverse events for the predicate device.

Technological Characteristics

Material: Beta-Tricalcium Phosphate (Ca3(PO4)2). Structure: Porous trabecular scaffold, ~90% porosity, 1-1000 µm pore size. Form factor: Morsels (1-4 mm) and blocks (9x23 mm). Energy source: None (passive implant). Sterilization: Gamma radiation. Connectivity: None.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic bone injuries requiring a bone void filler in the extremities, spine, or pelvis. Contraindicated for large defects that would not heal spontaneously or defects intrinsic to bony structural 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

• Pro Osteon 500R Resorbable Bone Void Filler

Reference Devices

• Osteoset (Wright Medical)

Submission Summary (Full Text)

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DEC 1 4 2000

K994337

## 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] | Angie Ide<br>Director, Regulatory Affairs |
| | Subject Device | Predicate Device | |
| | Vitoss™ Scaffold Synthetic<br>Cancellous Bone Void Filler | Pro Osteon 500R Resorbable<br>Bone Void Filler | |
| Common Name | Bone Void Filler | Bone Void Filler | |
| Classification Name | Filler, Calcium Sulfate<br>Preformed Pellets | Filler, Calcium Sulfate<br>Preformed Pellets | |
| | COMPARISON TO PREDICATE | | |
| | toss Scaffold | Pro Osteon 500R | |
| Intended Use | Synthetic Bone Void Filler | Synthetic Bone Void Filler | |
| Target Population | Individuals with bony defects<br>resulting from surgery or trauma | Individuals with bony defects<br>resulting from surgery or trauma<br>Bony voids or gaps of the | |
| Anatomical Locations | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and pelvis | skeletal system, i.e., the<br>extremities, spine and pelvis | |
| Labeling | Labeling contains same intended<br>use, contraindications,<br>warnings, precautions, and<br>adverse events as predicate | Labeling contains same intended<br>use, contraindications,<br>warnings, precautions, and<br>adverse events as Vitoss | |
| Materials ==================================================================================================================================================================== | | | |
| Chemical Composition | Calcium salt | Calcium salts | |
| Mineral Phase(s) | B-Tricalcium Phosphate<br>Ca3(PO4)2 | Hydroxyapatite<br>Cajo(PO4)g(OH)2<br>Calcium Carbonate CaCO3 | |
| Design | | | |
| - Physical Structure | Trabecular structure similar to<br>cancellous bone | Trabecular structure similar to<br>cancellous bone | |
| · Porosity | Approximately 90% | Approximately 55% | |
| · Pore Size (range | 1-1000um | 280-779um | |
| Performance | | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | |
| Resorption® | Demonstrated as 76% resorbed<br>at six weeks and 86% resorbed<br>at twelve weeks | Reported as 20% resorbed at six<br>weeks and 45% resorbed at<br>twelve weeks | |
| Bone Remodeling<br>Recorded as ratio of bone in<br>implant to adjacent be | Demonstrated as 0.6 at six<br>weeks and 1.2 at twelve weeks | Demonstrated as 0.4 at six<br>weeks and 0.5 at twelve weeks | |
| Mechanical Strength | Does not impart mechanical<br>strength to surgical site | Does not impart mechanical<br>strength to surgical site | |
| Sterility. | Sterilized by gamma radiation,<br>single use only | Sterilized by gamma radiation,<br>single use only | |
| Biocompatibility | Established | Established | |
| Dosage Form(s) | Morsels (1-4 mm sizes) and<br>blocks (9x23mm cylinder) | Morsels (1-4 mm sizes) | |

## 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 µm (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 only 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 gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void

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or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

## Comparison to Predicate:

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Summary of S & E Vitoss Scaffold Orthovita, Inc.

## Non-clinical Performance Data:

Pre-clinical animal data demonstrate that Vitoss Scaffold supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold resorbs at an early time period, accompanied by early bone ingrowth and bone remodeling. These results, in conjunction with biocompatibility data, demonstrate that Vitoss Scaffold Bone Void Filler is as safe and as effective as the predicate device, Pro Osteon 500R.

### Clinical Performance Data:

Calcium-based ceramic materials, including tricalcium phosphate, have been used in clinical practice for more than 25 years with no remarkable safety issues. Early successful results were achieved in dentistry and oral reconstructive surgery. Subsequently, successful results have been demonstrated in the treatment of many orthopedic problems, including filling defects secondary to trauma, benign turnors and cysts, and the filling of metaphyseal defects of long bones.

In terms of safety, calcium-based bone void fillers have the advantage of avoiding the potential morbidity associated with the harvesting of bone autografts and the potential for disease transmission by allografts. To date there have been no reports in the literature of adverse reactions to calcium-based ceramic materials. A review of FDA's Manufacturer and User Facility Device Experience Database (MAUDE), conducted on 12/13/1999, showed no records of adverse device experience with Pro Osteon 500R, the device to which Vitoss Scaffold claims substantial equivalence. Only two records were found reported for all devices with the product code MQV. These two records were for Wright Medical's product, Osteoset, the device to which Pro Osteon 500R was determined to be substantially equivalent. This confirms the continued safe use of the bone void fillers currently in commercial distribution.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, with three stylized wing segments and a flowing tail.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 4 2000

Ms. Angie Ide Director, Regulatory Affairs Orthovita Company 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K994337

Trade Name: Vitoss "Scaffold Synthetic Cancellous Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: October 26, 2000 Received: October 27, 2000

#### Dear Ms. Ide:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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#### Page 2 - Ms. Angie Ide

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vitoss Scaffold 510(k) Notification Orthovita, Inc. December 7, 2000

# INDICATIONS FOR USE STATEMENT

## 510(k) Number: K994337

Device Name: Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler

## Indications For Use:

Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only 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 gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). 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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| Division of General Restorative Devices<br>510(k) Number _ | |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use