BEUDAMED
    Product Code: QHE FDA class 2 21 CFR 888.3660

    Shoulder Arthroplasty Implantation System

    Orthopedic

    The Shoulder Arthroplasty Implantation System is a surgical instrument system designed to assist in the implantation of shoulder arthroplasty devices by guiding alignment, making or establishing cuts, and selecting, sizing, attaching, positioning, or orienting implant components. It is classified as FDA Class 2, meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is QHE, regulated under 21 CFR 888.3660, and falls under the Orthopedic medical specialty. It is not flagged as an implant or life-sustaining device, and is not exempt from Good Manufacturing Practices.

    View on FDA
    510(k)s
    26
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    10
    Years Active
    7

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    Basic Information

    Product Code
    QHE
    Device Class
    FDA class 2
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K260802 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K261510 Signature™ ONE System
    K260104 Signature™ ONE System
    K251558 Precision AI Surgical Planning System (PAI-SPS)
    K243509 Archer PSI System
    K241470 CORE Shoulder System
    K243955 Precision AI Surgical Planning System (PAI-SPS)
    K242813 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K241097 Arthrex Virtual Implant Positioning (VIP) System Software
    K233992 Precision AI Surgical Planning System (PAI-SPS)
    K241143 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K232425 Signature™ ONE System
    K233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K230904 Arthrex Virtual Implant Positioning (VIP) System
    K222007 Arthrex Virtual Implant Positioning (VIP) System
    K230315 Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
    K222405 Smart SPACE Shoulder Planner and 3D Positioners
    K220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
    K212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
    K212560 Signature™ ONE System
    K202151 Smart SPACE Shoulder System
    K202454 Smart SPACE Shoulder System
    K200615 Signature ONE System
    K193560 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
    K192074 Signature ONE System

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.