# K091031: Pioneer Surgical Nanoss BVF-E

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Nov 17, 2009 after 221 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: 5 generations back to K960978 (1996). 24 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC, Pioneer Surgical Technology (2008) Summary page 2.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 2.
- K050789: Formagraft Collagen Bone Graft Matrix, R and D Medical, LLC (2005). Our reading of the summary gave K050798, FDA’s number for Eclipse Neurological Workstation (Axon Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Formalraft'M Collagen Bone Graft Matrix”.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K111944: NB3D Bone Void Filler (2011), 1 descendant of its own

## Indications for use
Pioneer ForirOssBone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is indicated to be used in the posterolateral spine in conjunction with bone marrow aspirate and autograft 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/K091031
Methodology: https://510kreport.com/methodology