COMPORUS

K062691 · Takiron Co., Ltd. · MQV · Apr 15, 2008 · Orthopedic

Device Facts

• Record ID: K062691
• Device Name: COMPORUS
• Applicant: Takiron Co., Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus 100 is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Device Story

Comporus™ is an osteoconductive, biodegradable bone void filler; composed of poly-D/L-lactide and hydroxyapatite. Supplied as granules, blocks, or cylinders; manually packed into surgical sites. Device is radiopaque; intraoperatively modifiable via trimming or thermal transformation. Implant resorbs and is replaced by natural bone during healing. Used by surgeons in clinical settings for non-structural skeletal defects. Benefits include providing a scaffold for bone regeneration in traumatic or surgically created voids.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Osteoconductive biodegradable scaffold; mixture of poly-D/L-lactide and hydroxyapatite. Available in granule, block, and cylinder forms. Radiopaque. Sterile, single-use. Modifiable via trimming or thermal transformation. Compressive strength comparable to cancellous bone.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system, specifically extremities and pelvis, that are not intrinsic to bony stability. Applicable to surgically created osseous defects or defects resulting from traumatic injury.

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 (K980817)
• Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409)
• PolyGraft™ BGS; Bone Graft Substitute (K030288)
• Bi-Ostetic™ (K023703)

Submission Summary (Full Text)

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# 510(k) Summary

APR 1 5 2008

Comporus TM

| Submitter's name: | Takiron Co., Ltd. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address: | 3-13 Azuchi-machi 2-chome, Chuo-ku, Osaka<br>541-0052, Japan |
| Contact Person: | Kenshi Okazaki<br>Shikinami Laboratory, Medical Division<br>405 Nagano, Yasutomi-cho, Himeji, Hyogo,<br>671-2421, Japan<br>Phone: [phone]<br>Facsimile: [phone]<br>[e-mail] |
| Date prepared: | August 30, 2006 |
| Trade or proprietary name: | Comporus™ |
| Common name: | Resorbable Synthetic Bone Void Filler |
| Classification name: | Resorbable calcium salt bone void filler (Product<br>Code MQV) is a Class II device, per 21 CFR<br>888.3045. |

## Establishment Registration Number:

Takiron Co., Ltd. has not yet obtained an Establishment Registration Number.

## Legally Marketed Predicate Devices:

INTERPORE International; Pro Osteon® 500R Resorbable Bone Void Filler (K980817) Orthovita, Inc.; Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) OsteoBiologics, Inc.; PolyGraft™ BGS; Bone Graft Substitute (K030288) Berkeley Advanced Biomaterials, INC .; Bi-Ostetic™ (K023703)

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# Intended Use:

Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus 100 is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

# Device Description:

Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.

## Summary of Technology:

Comporus"14 has similar compressive strength to the predicate devices and cancellous bone. Comporus 100 has the similar technological characteristics (i.e., design and material) when compared to the predicate devices.

# Substantial equivalence:

The Comporus™ and the predicate devices have the same intended use and principles of operation and very similar technological characteristics. Furthermore, the minor technological differences between the Comporus" and the predicate devices do not raise any new issues of safety or effectiveness. Preclinical testing was performed and demonstrates that the device is substantially equivalent to the predicate. Therefore, the Comporus 1M is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2008

Takiron Co., Ltd. % Medical Division Dr. Kenshi Okazaki 405 Nagano, Yasutomi-Cho Himeji Japan 671-2421

Re: K062691

Trade/Device Name: ComporusTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 18, 2008 Received: January 22, 2008

Dear Dr. Okazaki:

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 -- Dr. Kenshi Okazaki

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 vours,

Mark M. Mulhern

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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#### INDICATIONS FOR USE

Applicant: Takiron Co., Ltd. 510(k) Number (if known):_ K062691 Device Name: __ Comporus™M

#### Indications For Use:

Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new 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 if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Syha Sarka

(Division Sign-(Division of General, Restorative, Division of Neurological Devices

**510(k) Number** K06269