BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TITAN MODULAR TOTAL SHOULDER SYSTEM

    K Number: K112438 · Decision Apr 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    7
    Review Days
    231

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TITAN MODULAR TOTAL SHOULDER SYSTEM
    K Number
    K112438
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedic
    Date Received
    August 24, 2011
    Decision Date
    April 11, 2012
    Product Code
    KWS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KWS), ordered by most recent decision date.

    AETOS Shoulder System - CONCELOC Glenoids

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Catalyst F1x Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AETOS Shoulder System Meta Humeral Prosthesis Size 0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MyShoulder Planner (5.3SSWPL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System (Tornier HRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Ascension Orthopedic

    K Number Device Name
    K140463 INTEGRA EXTERNAL FIXATION SYSTEM
    K131360 INTEGRA TITANIUM BONE WEDGE
    K130050 TITAN REVERSE SHOULDER SYSTEM
    K112481 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
    K112278 ASCENSION NUGRIP CMC IMPLANT
    K111799 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM