# K141841: Integra Mozaik Osteoconductive  Scaffold - Strip

- Pathway: 510(k) (Special)
- Applicant: Integra Lifescience Corportation
- Decided: Aug 1, 2014 after 24 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)
- K063124: Integra Mozaik Bone Regeneration Matrix - Strips, Integra Lifesciences Corp. (2007) Summary page 4.

## Indications for use
Integra MOZAIK™ Osteoconductive Scaffold – Strip 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™ Osteoconductive Scaffold – Strip 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™ Osteoconductive Scaffold – Strip is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K141841
Methodology: https://510kreport.com/methodology