# K122868: Biosphere Bioactive Bone Graft Putty

- Pathway: 510(k) (Traditional)
- Applicant: Synergy Biomedical, LLC
- Decided: Apr 19, 2013 after 213 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). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060728: Novabone Putty - Bioactive Synthetic Graft, Novabone Products, LLC (2006) Summary page 1.
- K031399: Intergro DBM, Interpore Cross Intl. (2005) Summary page 1.

## Most influential descendants
- K140844: Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC (2014), 1 descendant of its own
- K173424: BioSphere Flex (2018), 0 descendants of its own
- K173301: BioSphere MIS Putty (BioSphere MIS) (2018), 0 descendants of its own

## Indications for use
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities 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 with bone during the healing process.

Source page: https://510kreport.com/device/K122868
Methodology: https://510kreport.com/methodology