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510(k) Data Aggregation

    K Number
    K250297
    Date Cleared
    2025-10-27

    (269 days)

    Product Code
    Regulation Number
    882.5320
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K121818, K141452, K230276, K222577, K192502

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TECHFIT Patient-Specific Cranial System is intended to replace bony voids in the cranial skeleton. The devices are indicated for adults and adolescents from 18 years or older.

    Device Description

    The TECHFIT Patient-Specific Cranial System is patient specific devices intended to replace bony voids in the cranial/craniofacial skeleton. The TECHFIT Patient-Specific Cranial System includes a cranial implant, cranial model and a software component for digital planning and visualization named Digitally Integrated Surgical Reconstruction Platform DISRP®.

    TECHFIT Patient-Specific Cranial Implants are manufactured from Polyether Ether Ketone (PEEK). The TECHFIT Patient-Specific Cranial Implants are attached to the native bone using commercial plates and screws.

    The TECHFIT Patient-Specific Cranial System matches the shape and dimensions of the missing skull bone fragments. The implants are manufactured from PEEK according to ASTM F2026 and are manufactured by machining process.

    The TECHFIT Patient-Specific Cranial System models are patient specific devices manufactured from clear resin using 3D printing manufacturing process. Those models are a representation of the anatomy of the patient, and they are not indicated to enter to the OR (Operating Room).

    AI/ML Overview

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