THERIFIL BONE FILLER

K031040 · Therics, Inc. · MQV · Jul 24, 2003 · Orthopedic

Device Facts

• Record ID: K031040
• Device Name: THERIFIL BONE FILLER
• Applicant: Therics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.

Device Story

TheriFil™ is a synthetic bone void filler composed of beta-tricalcium phosphate. It is designed to fill gaps or voids in osseous defects of the extremities, spine, and pelvis that are not intrinsic to bone stability. The device is implanted by a surgeon into the defect site, where its porous, geometric structure creates an interlocking network. This network acts as a scaffold that resorbs over time as it is replaced by the patient's native bone during the healing process. The device provides a synthetic alternative to bone grafts for non-structural bone voids.

Clinical Evidence

No human clinical data provided. Evidence consists of pre-clinical performance testing in a canine animal model comparing TheriFil™ to the predicate device (Vitoss™). Results showed similar tissue reaction, bone ingrowth, residual material, and mechanical testing outcomes.

Technological Characteristics

Constructed of synthetic beta-tricalcium phosphate. Porosity ~60%; mean pore diameter 60 ± 12 µm; true density 1.530 ± 0.001 g/mL. Designed as a resorbable scaffold for bone ingrowth. No software or electronic components.

Indications for Use

Indicated for filling osseous defects in the skeletal system (extremities, spine, pelvis) caused by surgery or trauma; intended for defects not intrinsic to bone 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

• Orthovita's Vitoss™
• Wright Medical's WMT-TCP Bone Graft Substitute

Submission Summary (Full Text)

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JUL 2 4 2003

K 03/090

Attachment - 6

# 510(k) Summary

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THERICS, INC. 115 CAMPUS DRIVE RINCETON, NJ 0854 ELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: [e-mail]

Image /page/1/Picture/1 description: The image contains the word "THERICS" in a stylized font. To the left of the word is a pattern of black dots arranged in a grid-like fashion. Above the word, there is some handwritten text that appears to be "K03/040". There is also the number "03" on the left side of the image.

JUL 2 4 2003

### 510(k) SUMMARY

# Therics' TheriFil™ Bone Void Filler

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

Submitter's Name:

Umberto V. Parrotta

609.514.7237 or 609.514.7200 (main) Telephone: Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta

Date Prepared:March 31, 2003

### Name of Device and Name/Address of Sponsor

# TRADE/PROPRIETARY NAME OF DEVICE:

TheriFil™ Bone Void Filler

### ADDRESS:

115 Campus Drive Princeton, New Jersey 08540

### Common or Usual Name:

Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute

### Classification Name

Bone Void Filler

### Predicate Devices

Orthovita's Vitoss™ Wright Medical's WMT-TCP Bone Graft Substitute

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THERICS, INC. 15 CAMPUS DRIVE RINCETON, NJ 08540 TELEPHONE: [phone] FAX' E-MAIL: [e-mail]

Image /page/2/Picture/1 description: The image shows the word "THERICS" next to a square made up of circles. The circles are arranged in a grid pattern, with the circles on the left side of the square being lighter and the circles on the right side of the square being darker. The word "THERICS" is written in a sans-serif font and is slightly offset to the right of the square. The image is black and white.

### Intended Use / Indications for Use

TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.

### Technological Characteristics and Substantial Equivalence

The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.

A summary of the physical and chemical characteristics of both TheriFilTM and Vitoss™ is below in Table 1.

| Characteristic | | TheriFilTM | VitossTM |
|---------------------------------|------|-----------------------|-----------------------|
| Porosity | | ~60% | ~80% |
| Pore Area (µm2) | Mean | $3000 \pm 1200$ | $2700 \pm 2200$ |
| | Min* | 40 | 40 |
| | Max | $3.5x10^5 + 2.1x10^5$ | $5.7x10^5 + 3.3x10^5$ |
| Pore diameter (µm) | Mean | $60 \pm 12$ | $56 \pm 19$ |
| | Min* | 7 | 7 |
| | Max | $640 \pm 220$ | $810 \pm 270$ |
| True Density (grams/mL) | | $1.530 \pm 0.001$ | $1.527 \pm 0.002$ |
| Bulk Packing Density (grams/mL) | | $0.53 \pm 0.02$ | $0.22 \pm 0.02$ |
| Packing Porosity (%) | | $65.7 \pm 1.4$ | $85.8 \pm 1.0$ |

#### Table 1. Physical characteristics of the TheriFil™ and Vitoss™ bone void fillers.

Percent porosity and pore area (um") were estimated using SEM images (n = 30) and are described in Attachment 134, Porosity Characterization. Data are shown as ave + stdev. The pore diameter was estimated from the pore area by assuming circular shaped pores. *All finite (< 40 um') pore structures were excluded from the analysis and therefore the minimum pore area is represented by 40um² and the pore diameter by 7um. The true density was measured using a pycnometer. Methods describing bulk packing porosity and described in Attachment - 13B, Implant Packing Characterization.

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Image /page/3/Picture/1 description: The image shows the word "THERICS" in a stylized font, with a pattern of black circles to the left of the word. The circles are arranged in a grid-like pattern, with the density of the circles decreasing from left to right. The word "THERICS" is in a sans-serif font, and the letters are slightly distorted, giving them a textured appearance. The overall effect is modern and technological.

Pre-clinical performance testing conducted on TheriFil™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reaction, bone ingrowth, residual material, and mechanical testing.

The TheriFil™ implants have the same intended use and indications, the same or similar principals of operation and technological characteristics, and equivalent performance in an appropriate animal model. Therefore, Theric's TheriFil™ Bone Void Filler is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with wavy lines below them.

Public Health Service

JUL 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Umberto V. Parrotta, Jr. 115 Campus Drive Therics, Inc. Princeton, NJ 08540

Re: K031040

Trade Name: TheriFil 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: March 31, 2003 Received: April 1, 2003

Dear Mr. Parrotta:

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. Umberto V. Parrotta, Jr.

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 vours,

Sincerely yours,

Mark N Millenson

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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## CONFIDENTIAL

### Attachment - 12

### Indications for Use Form

510(k) Number (if known): K031040.

Device Name:

TheriFil™ Bone Void Filler

Indications for Use:

TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e., the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------|----------------------|
| | (Division Sign-on) | |
| | Division of Ge Restorative and Neurological Devices | |
| 510(k) Number | K031040 | |
| Prescription Use (Per 21 C.F.R. 801.109)<br><div style="font-size: 2em;">✓</div> | OR | Over-The-Counter Use |

(Optional Format 1-2-96)