# K070012: Polybone

- Pathway: 510(k) (Traditional)
- Applicant: Kyung Won Medical Co., Ltd.
- Decided: Dec 27, 2007 after 358 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K873689 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043334: Bone Source Hac Rapid Setting Cement, Stryker Instruments (2005) Summary page 1.

## Indications for use
PolyBone is a selflsetting, calcium proosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defdcts as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Source page: https://510kreport.com/device/K070012
Methodology: https://510kreport.com/methodology