# K161351: NanoBone SBX Putty

- Pathway: 510(k) (Traditional)
- Applicant: Artoss GmbH
- Decided: Oct 26, 2016 after 163 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: 5 generations back to K960978 (1996). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141189: Nanobone / Granulate, Artoss GmbH (2015) Summary page 4.
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 4.

## Most influential descendants
- K190110: NanoBone SBX PUTTY, NanoBone QD (2019), 0 descendants of its own

## Indications for use
NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities 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/K161351
Methodology: https://510kreport.com/methodology