# K062353: Mozaik Bone Regeneration Matrix - Putty

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 20, 2006 after 131 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032288 (2003). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 1.

## Most influential descendants
- K231030: Cove Putty, OsteoCove Putty (2023), 0 descendants of its own
- K091302: Integra Mozaik and OS Moldable Morsels (2009), 0 descendants of its own

## Recalls of this device
- Oct 11, 2011 · Class II · Z-1796-2012: The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow
- Oct 7, 2011 · Not classified · Z-0986-2012: Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
- Jan 16, 2009 · Not classified · Z-1034-2009: Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

## Indications for use
Integra MOZAIKTM Osteoconductive Scaffold - Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Putty is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Putty is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K062353
Methodology: https://510kreport.com/methodology