# K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, I
- Decided: Oct 17, 2014 after 123 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). 27 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110561: Fortross Bone Void Filler, Pioneer Surgical Technology (2011) Summary page 4.
- K100361: Nanoss Bone Void Filler, Pioneer Surgical Technology (2010) Summary page 4.

## Most influential descendants
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own
- K242797: OsteoFlo HydroFiber (2024), 1 descendant of its own
- K243949: OsteoFlo HydroFiber (2025), 0 descendants of its own

## Indications for use
NanOss™ is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K141600
Methodology: https://510kreport.com/methodology