# K070794: Atlantik

- Pathway: 510(k) (Abbreviated)
- Applicant: Medical Biomat
- Decided: Jul 10, 2007 after 110 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 K990131 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051774: MBCP, Biomatlante (2006)
- K030131: Ossatura BCP Bone Void Filler, Isotis NV (2003) Summary page 1.

## Indications for use
ATLANTIKTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ATLANTIKTM is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

Source page: https://510kreport.com/device/K070794
Methodology: https://510kreport.com/methodology