# K082338: Polybone Granule & Block

- Pathway: 510(k) (Traditional)
- Applicant: Kyung Won Medical Co., Ltd.
- Decided: Oct 16, 2008 after 63 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kasios TCP: named in the summary without a submission number
- (no number) Vitoss Scaffold: named in the summary without a submission number

## 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.

Source page: https://510kreport.com/device/K082338
Methodology: https://510kreport.com/methodology