# K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Aug 25, 2008 after 83 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). 16 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 2.
- K050025: Nanoss Bone Void Filler, Angstrom Medica, Inc. (2005) Summary page 2.
- K043421: Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip IC, Regeneration Technologies, Inc. (2005) Summary page 2.
- K060728: Novabone Putty - Bioactive Synthetic Graft, Novabone Products, LLC (2006) Summary page 2.

## Most influential descendants
- K091031: Pioneer Surgical Nanoss BVF-E (2009), 7 descendants of its own
- K110561: Fortross Bone Void Filler (2011), 4 descendants of its own
- 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

## Indications for use
NanOss 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 osscous 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/K081558
Methodology: https://510kreport.com/methodology