# K100361: Nanoss Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology
- Decided: Apr 22, 2010 after 69 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NanOss BVF-E: named in the summary without a submission number

## Most influential descendants
- K141600: Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit (2014), 3 descendants of its own
- 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
NanOSSTm BVF-E 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 (extremities, pelvis). 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 by the growth of new bone during the healing process.

Source page: https://510kreport.com/device/K100361
Methodology: https://510kreport.com/methodology