THERILINK BONE VOID FILLER

K040134 · Therics, Inc. · MQV · Mar 9, 2004 · Orthopedic

Device Facts

• Record ID: K040134
• Device Name: THERILINK BONE VOID FILLER
• Applicant: Therics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheriLink™ 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.

Device Story

Synthetic bone void filler; composed of beta-tricalcium phosphate (β-TCP). Implanted into skeletal defects (extremities, spine, pelvis) to fill gaps/voids; creates porous network within defect site. Material resorbs during healing process; replaced by native bone. Used by surgeons in clinical settings. Provides scaffold for bone ingrowth; facilitates healing of non-load-bearing defects.

Clinical Evidence

Bench testing only. Physical and chemical characterization (porosity, pore area, pore diameter, density, crystallinity) performed using SEM imaging (n=18) and pycnometer analysis. No clinical data provided.

Technological Characteristics

Synthetic β-tricalcium phosphate (β-TCP) bone void filler. Porosity: 58 ± 2.2%. Mean pore diameter: 55 ± 11 µm. True density: 1.5 g/mL. Crystallinity: β-TCP > 75%. Mechanical/structural scaffold.

Indications for Use

Indicated for filling surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis) that are 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

• Therics' TheriFil™ Bone Void Filler
• Orthovita's Vitoss™

Submission Summary (Full Text)

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KO40134 THERICS' ャートは1人を見える11、そのために1本に1人に

THERICS, INC. I 15 Campus Drive PRINCETON, NJ 08540 TELEPHONE: [phone] FAX: E-MAIL: [e-mail]

MAR - 9 2004

### 510(k) SUMMARY

# Therics' TheriLink™ 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: January 19, 2004

# Name of Device and Name/Address of Sponsor

# TRADE/PROPRIETARY NAME OF DEVICE:

TheriLink™ 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

Therics' TheriFil™ Bone Void Filler Orthovita's Vitoss™

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THERICS, INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: [phone] FAX: E-MAIL: [e-mail]

Image /page/1/Figure/1 description: The image shows a logo for a company called "THERICS". The logo features a stylized letter "T" above the company name. Below the company name, the text "LASER ENGINEERING SPECIALISTS" is present, indicating the company's area of expertise.

### Intended Use / Indications for Use

cu ose / Indications 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.

# Technological Characteristics and Substantial Equivalence

The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a 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 TheriLink™ and TheriFil™ is below in Table 1.

| Characteristic | TheriLink™ | TheriFil™ |
|-------------------------|--------------------------------|-------------------------|
| Porosity (%) | 58 ± 2.2 | 59 ± 5.3 |
| Pore Area (µm²) | Mean<br>2500 ± 900 | 3000 ± 1200 |
| | Min*<br>40 | 40 |
| | Max<br>$4.9 x10^5 ± 1.9 x10^5$ | $3.5 x10^5 ± 2.1 x10^5$ |
| Pore diameter (µm) | Mean<br>55 ± 11 | 60 ± 12 |
| | Min*<br>7 | 7 |
| | Max<br>770 ± 170 | 640 ± 220 |
| True Density (grams/mL) | 1.5 | 1.5 |
| Crystallinity | β-TCP > 75% | β-TCP > 75% |

# Table 1. Physical and chemical characteristics of the TheriLink™ and TheriFil™ .

Percent porosity and pore area (um') were estimated using SEM images (n = 18) and are described in Attachment - 13A, I crosity Characterization. Data are shown as ave ± sidev. The pore diameter was estimated from the pore area by assuming r circular shaped pores. * All finite (< 40 um') pore structures were excluded from the analysis and therefore the minimum porc e realis represented by 40um and the pore diameter by 7um. The true density was measured using a pycnometer.

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THERICS, INC. 115 Campus Drive PRINCETON, NJ 08540 TELEPHONE: [phone] FAX: E-MAIL: [e-mail]

Image /page/2/Figure/1 description: The image shows a logo with the word "THERICS" in a stylized font. Below the word "THERICS" is the text "VISCOR ENGINEERING SPECIALISTS". Above the word "THERICS" is a symbol that looks like a "T" made of plus signs.

The risk assessment comparing the design of TheriLink™ to TheriFir™ indicates I he TISK assessment comparing the design, appearing consistent with similar FDA cleared and marketed products (i.e. Orthovita's Vitoss™).

The TheriLink™ implants have the same intended use and indications, the same THE THENDS - Implants nation and technological characteristics, and equivalent of simmal principals or operepriate bench studies, and risk assessment. performance of characteristics in appeared in substantially equivalent to the predicate device.

Attachment - 6

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem consisting of three stylized horizontal lines that appear to be flowing or waving.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Therics, Inc. C/o Jonathan S. Kahan Hogan & Hartson, LLP 555 13th St. NW Washington, DC 20004

Re: K040134

Trade/Device Name: TheriLink™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: January 21, 2004 Received: February 9, 2004

Dear Mr. Kahan:

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 - Jonathan S. Kahan

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,

R. Mark A. Millerson

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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Image /page/5/Picture/0 description: The image shows a logo for a company called "THERICS". The logo features a stylized "T" symbol above the company name. The "T" symbol is made up of a series of plus signs arranged in a cross shape. The company name is written in a bold, sans-serif font.

## CONFIDENTIAL

### Attachment - 11

### Indications for Use Form

510(k) Number (if known):

Device Name:

TheriLink™ Bone Void Filler

Indications for Use:

TheriLink™ 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.

v Prescription Use (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) Division of General, Restorative, and Neurological Devices Koy 0134

File: Attachment-11-TheriLink-IndicationsForUseStatementForm.doc

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