# K161996: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

- Pathway: 510(k) (Traditional)
- Applicant: Amend Surgical, Inc.
- Decided: Feb 16, 2017 after 212 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: 7 generations back to K960978 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142104: Nanofuse DBM, Nanotherapeutics, Inc. (2015) Summary page 4.

## Indications for use
NanoFUSE® is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K161996
Methodology: https://510kreport.com/methodology