# K253524: Adaptos®Fuse Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Biomendex OY
- Decided: Feb 17, 2026 after 96 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: 10 generations back to K960978 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240404: NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615), Novabone Products, LLC (2024) Summary page 5.
- K071046: Synthes Chronos Composite, Synthes (Usa) (2007) Summary page 5.
- K043045: Synthes (Usa) Chronos, Synthes (Usa) (2005) Summary page 5.

## Indications for use
Adaptos®Fuse Bone Graft is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone (i.e., posterolateral spine, intervertebral disc space, and pelvis). In interbody fusion procedures, Adaptos®Fuse Bone Graft must be used with interbody fusion devices FDA cleared for use with bone void filler. Adaptos®Fuse Bone Graft Granules must be mixed with autograft prior to use. Following placement in the bony void or gap, Adaptos®Fuse Bone Graft are resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K253524
Methodology: https://510kreport.com/methodology