# K141189: Nanobone / Granulate

- Pathway: 510(k) (Traditional)
- Applicant: Artoss GmbH
- Decided: Jan 30, 2015 after 267 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: 4 generations back to K960978 (1996). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040082: Pore-SI Bone Graft Substitute, Apatech, Ltd. (2004) Summary page 4.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 4.
- K060432: Novabone Porous-Bone Graft Scaffold, Novabone Products, LLC (2006) Summary page 4.
- K041613: Novabone - AR - Resorbable Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 4.

## Most influential descendants
- K161351: NanoBone SBX Putty (2016), 1 descendant of its own
- K190110: NanoBone SBX PUTTY, NanoBone QD (2019), 0 descendants of its own

## Indications for use
NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are 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/K141189
Methodology: https://510kreport.com/methodology