# K173424: BioSphere Flex

- Pathway: 510(k) (Traditional)
- Applicant: Synergy Biomedical
- Decided: Sep 12, 2018 after 315 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122868: Biosphere Bioactive Bone Graft Putty, Synergy Biomedical, LLC (2013) Summary page 4.

## Indications for use
BioSphere Flex is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Flex 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. BioSphere Flex must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K173424
Methodology: https://510kreport.com/methodology