# K111018: Polyfuse - Neurobone

- Pathway: 510(k) (Traditional)
- Applicant: Atpac Medical, LLC
- Decided: Feb 14, 2012 after 308 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
Longest line of descent: 1 generation back to K042340 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042340: Kasios TCP, Kasios Biomaterials (2004) Summary page 1.

## Indications for use
OsteoLaso Granules & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the boney structure. OsteoLaso Granules & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granules & Strips are intended to be packed into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremities posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K111018
Methodology: https://510kreport.com/methodology