# K091302: Integra Mozaik and OS Moldable Morsels

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 4, 2009 after 214 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 K032288 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062353: Mozaik Bone Regeneration Matrix - Putty, Integra LifeSciences Corporation (2006) Summary page 1.

## Indications for use
The Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels, combined with bone marrow aspirate, are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine (posterolateral spinal fusions only), and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are also indicated for use in the treatment of surgically treated osseous defects or osseouIs defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra Mozaik Moldable Morsels and Integra OS Moldable Morsels are resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K091302
Methodology: https://510kreport.com/methodology