# K050025: Nanoss Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Angstrom Medica, Inc.
- Decided: Feb 3, 2005 after 28 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: 3 generations back to K960978 (1996). 8 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011531: Calcium Phosphate Granular Bone Void Filler, Biomet, Inc. (2002)
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 2.
- K010532: Osteoset BVF Kit, Wrightmedicaltechnologyinc (2001) Summary page 2.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 2.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 2.

## Most influential descendants
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC (2008), 10 descendants of its own
- 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

## Indications for use
NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous 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/K050025
Methodology: https://510kreport.com/methodology