Integra Mozaik and OS Moldable Morsels

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K091302 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• DuraGen® Suturable

  Class III

  CE/MDD

• Mayfield®

  Class I

  CE/MDR

• Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models

  Class II

  FDA 510(k) K140722 Active Cleared 6 Jan 2015

• INTEGRA Wound Matrix (Macro-Channels)

  Unclassified

  FDA 510(k) K210128 Active Cleared 8 Oct 2021

• Mayfield Radiolucent Disposable Skull Pins

  Class II

  FDA 510(k) K071458 Active Cleared 13 Jun 2007

• Licox Pmo Brain Monitoring System

  Class II

  FDA 510(k) K040235 Active Cleared 20 Apr 2004

See all devices from Integra Lifesciences Corporation →

• What are the Integra Mozaik and OS Moldable Morsels used for?

  These devices are designed as bone void fillers and osseous scaffolds to fill surgically created or traumatic bone defects. Their collagen-based, moldable putty-like composition supports structural integrity and promotes bone regeneration by facilitating cellular ingrowth. They are specifically intended for orthopedic procedures where stable, biocompatible filling is required, such as filling gaps or cavities in bone to restore function and encourage new bone tissue formation.

• How are the Integra Mozaik and OS Moldable Morsels supplied and prepared for use?

  The morsels are supplied as sterile, single-use materials exclusively for surgical applications. They are manually molded during surgery to conform to irregular bone defects, allowing clinicians to customize the fit for the patient’s specific anatomical needs. The sterile packaging ensures they remain uncontaminated until use, adhering to standard surgical sterile protocols.

• Are the Integra Mozaik and OS Moldable Morsels reusable or intended for single-use?

  These morsels are explicitly designed for single-use only. They are not intended to be reprocessed or reused after a surgical procedure, as this could compromise sterility and integrity. The device’s sterile packaging and intended use align with single-patient, single-procedure applications to maintain safety and efficacy.

• What storage and handling precautions should be taken with these morsels?

  The Integra Mozaik and OS Moldable Morsels must be stored and handled according to sterile surgical protocols to preserve their sterility. This includes keeping them in their original, unopened packaging until immediately before use and avoiding exposure to contaminants or moisture. Proper storage conditions ensure the material remains intact and ready for surgical application without degradation.

• Are there specific sizes or formulations available for these morsels?

  The morsels come in various sizes and formulations tailored to different bone defect sizes and clinical needs. While the exact specifications are detailed in the original submission data, the product is designed to be adaptable for manual molding during surgery. Clinicians can select the appropriate size and formulation based on the defect’s characteristics to achieve optimal fit and integration with surrounding bone tissue.