POLYBONE GRANULE & BLOCK

K082338 · Kyung Won Medical Co., Ltd. · MQV · Oct 16, 2008 · Orthopedic

Device Facts

• Record ID: K082338
• Device Name: POLYBONE GRANULE & BLOCK
• Applicant: Kyung Won Medical Co., Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.

Device Story

PolyBone® Granule & Block is a synthetic, resorbable bone void filler composed of 99.99% beta-tricalcium phosphate and 0.01% polyphosphate. It functions as an osteoconductive scaffold to support bone regeneration. The material features multidirectional interconnected porosity (75-85%) with pore sizes ranging from 200-500 μm. During the healing process, bone cells resorb the polyphosphate, and the scaffold is gradually replaced by new bone. The device is provided in various shapes and sizes for surgical implantation into bony voids or gaps in the skeletal system, such as the extremities, spine, or pelvis. It is intended for use by surgeons to fill defects that do not require intrinsic structural stability.

Clinical Evidence

No clinical data. Biocompatibility testing was performed in accordance with ISO 10993-1:2003, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, and implantation studies. Results demonstrated the device is biologically safe.

Technological Characteristics

Synthetic resorbable bone void filler; 99.99% beta-tricalcium phosphate, 0.01% polyphosphate. Porous scaffold structure; 75-85% porosity; 200-500 μm pore size. Available in granule and block forms. Biocompatibility tested per ISO 10993-1:2003.

Indications for Use

Indicated for filling non-structural bone voids or defects in the skeletal system, including extremities, spine, and pelvis. Applicable to surgically created osseous defects or those resulting from traumatic injury. Not for use where structural stability is required.

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

• Kasios TCP
• Vitoss Scaffold

Submission Summary (Full Text)

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K082338 (pg 1 of 2)

(yungwon Medical Co., Ltd.

Confidential

### 510(k) Summary

### OCT 1 6 2008

#### Date: 8-11-2008

- 1. Company making the submission

| | Submitter |
|---------|--------------------------------------------------------------------------------------------------|
| Name | Kyungwon Medical Co.,Ltd |
| Address | Suite 601 World Meridian Venture Center, 60-24<br>Gasan-Dong, Geumcheon-Gu, Seoul, Korea 153-801 |
| Phone | [phone]~8 |
| Fax | [phone] |
| Contact | Shim, JaeBum Ph.D. Technical Director |
| Website | http://www.kyungwonmedical.co.kr |

- 2. Device:
Trade Name: PolyBone® Granule & Block Common Name: Bone Void Filler Classification Name: Resorbable Calcium Salt Bone Void Filler

- 3. Predicate Device: Kasios TCP, Vitoss Scaffold.
#### 4. Description:

PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size.

Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions.

The device is available in a variety of shape and sizes.

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KO82338

Kyungwon Medical Co., Ltd.

Confidential

- 5. Indication for use:
PolyBone® Granule & Block is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be gently packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and is replaced with bone during the healing process.

#### 6. Review:

PolyBone® Granule & Block has the similar technological characteristics to the predicate device; components, indication for use, chemical and performance properties.

Components Similarities All devices are packed with a container

Indication for Use Similarities All devices have the same indication for use

Chemical Similarities All devices are made up from ß-Tricalcium phosphate family

Performance Properties Similarities

All devices are for filling bone voids or defects that are not intrinsic to the stability of the bony structure.

#### Biocompatibility

The biocompatibility of PolyBone® Granule & Block has been performed by ISO10993-1:2003; cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity and implantation. The testing results show PolyBone® Granule & Block to be biologically safe.

#### 7. Conclusion

Based on the information provided in this premarket notification Kyungwon Medical Co.,Ltd. Concludes that PolyBone® Granule & Block is safe and effective and substantially equivalent to predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

OCT 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kyungwon Medical Co., Limited % Kodent, Inc. Jung Bae Bang US Agent 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K082338

Trade/Device Name: PolyBone® Granule & Block Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 11, 2008 Received: August 15, 2008

Dear Jung Bae Bang:

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 – Jung Bae Bang

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 the reporting 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 N. Millison

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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# Indication for Use

6082338 510(k) Number (if known)

# Device Name: PolyBone® Granule & Block

## Indications for Use:

PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.

Prescription Use X (21CRF 801 Subpart D)

Over-The-Counter Use AND/OR (21CRF 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | 14082338 |
|---------------|----------|
|---------------|----------|