# K193168: Agilon Moldable

- Pathway: 510(k) (Traditional)
- Applicant: Biogennix, LLC
- Decided: Feb 13, 2020 after 90 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: 7 generations back to K960978 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142828: osteoSPAN Morpheus, Biogennix (2015) Summary page 4.

## Indications for use
Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K193168
Methodology: https://510kreport.com/methodology