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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "PolyBone® Granule & Block," which is a resorbable calcium salt bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy through studies with acceptance criteria for device performance.

Therefore, the document does not contain information related to acceptance criteria, specific device performance metrics, or a study of the device's clinical performance against such criteria. It relies on similarity to predicate devices and biocompatibility testing.

Here's an explanation based on the information provided and what is typically found in a 510(k) for this type of device:

1. Table of acceptance criteria and the reported device performance:

Not applicable / Not provided. The 510(k) submission for "PolyBone® Granule & Block" does not detail performance acceptance criteria for clinical outcomes (e.g., bone regeneration rate, fusion success rate) or specific device functions beyond its material properties and chemical composition. The "performance properties similarities" section refers to its intended use and material characteristics, not quantitative performance metrics.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. No test set for clinical performance is described as this is a 510(k) submission based on substantial equivalence, not a clinical trial. The "test set" mentioned in typical AI/ML studies is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Ground truth determination by experts for a test set is specific to studies evaluating diagnostic or predictive algorithms, which is not the nature of this submission.

4. Adjudication method for the test set:

Not applicable / Not provided. Adjudication methods are used in studies involving expert review of data, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable / Not provided. MRMC studies are conducted for diagnostic imaging devices or AI-assisted diagnostic tools. "PolyBone® Granule & Block" is a bone void filler, a therapeutic device, thus this type of study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable / Not provided. This question pertains to AI/ML algorithms. "PolyBone® Granule & Block" is a physical medical device (bone void filler), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. As no clinical performance study against specific criteria is described, there's no mention of a "ground truth" for clinical outcomes. The "ground truth" for this device largely rests on its chemical composition being consistent, its biocompatibility, and its mechanical properties being suitable for its intended use as a bone void filler, and its similarity to established predicate devices.

8. The sample size for the training set:

Not applicable / Not provided. This question is relevant for AI/ML models. No training set is mentioned as this is a physical medical device.

9. How the ground truth for the training set was established:

Not applicable / Not provided. Similar to point 8, this is not relevant for this device.

Summary of the K082338 Submission:

The K082338 submission for PolyBone® Granule & Block primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Kasios TCP, Vitoss Scaffold) by showing similarities in:

Components: All devices are packed in a container.
Indication for Use: All devices have the same indication for use: filling bone voids or defects that are not intrinsic to the stability of the bony structure.
Chemical Similarities: All devices are made up of the ß-Tricalcium phosphate family. (PolyBone® is 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate).
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 device underwent ISO10993-1:2003 testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, and implantation) and was found to be "biologically safe."

The FDA's review concluded that the device is "safe and effective and substantially equivalent to predicate device." This means it does not present new questions of safety or effectiveness compared to the predicate devices, and therefore does not require extensive new clinical studies to prove efficacy against defined acceptance criteria.

Summary

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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, 60-24Gasan-Dong, Geumcheon-Gu, Seoul, Korea 153-801
Phone	+82-2-2113-8693~8
Fax	+82-2-2113-8699
Contact	Shim, JaeBum Ph.D. Technical Director
Website	http://www.kyungwonmedical.co.kr

1. Device:
  Trade Name: PolyBone® Granule & Block Common Name: Bone Void Filler Classification Name: Resorbable Calcium Salt Bone Void Filler
1. Predicate Device: Kasios TCP, Vitoss Scaffold.

4. Description:

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

1. 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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:

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
---------------	----------

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
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.(b)
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.