# K190110: NanoBone SBX PUTTY, NanoBone QD

- Pathway: 510(k) (Traditional)
- Applicant: Artoss GmbH
- Decided: Apr 23, 2019 after 90 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: 6 generations back to K960978 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161351: NanoBone SBX Putty, Artoss GmbH (2016) Summary page 5.

## Indications for use
NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process. NanoBone® QD Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD Putty resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K190110
Methodology: https://510kreport.com/methodology