# K080065: Osferion

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Terumo Biomaterials Corporation
- Decided: May 2, 2008 after 113 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: 2 generations back to K013072 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043045: Synthes (Usa) Chronos, Synthes (Usa) (2005) Summary page 2.
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 2.
- K061499: Osferion, Olympus America, Inc. (2007) Summary page 2.

## Indications for use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K080065
Methodology: https://510kreport.com/methodology