# K142828: osteoSPAN Morpheus

- Pathway: 510(k) (Traditional)
- Applicant: Biogennix
- Decided: Jan 15, 2015 after 107 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: 6 generations back to K960978 (1996). 11 ancestors in all.
2 later devices descend from it; 2 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)
- K093342: Biogennix RPC, Biogennix, LLC (2010) Summary page 5.
- K132377: Osteospan Morpheus, Biogennix, LLC (2014) Summary page 5.

## Most influential descendants
- K193487: Agilon Strip (2020), 0 descendants of its own
- K193168: Agilon Moldable (2020), 0 descendants of its own

## Indications for use
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.

Source page: https://510kreport.com/device/K142828
Methodology: https://510kreport.com/methodology