BEUDAMED
    Product Code: MBF FDA class 2 21 CFR 888.3670

    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

    Orthopedic

    The semi-constrained uncemented metal/polymer shoulder prosthesis is an orthopedic implant designed to replace the glenohumeral joint surfaces in patients with shoulder arthritis or rotator cuff deficiency, providing joint stability through its semi-constrained design and bone ingrowth fixation. It is classified as FDA Class II under 21 CFR 888.3670 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBF and it carries an implant flag. Full GMP quality system requirements apply.

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    510(k)s
    35
    FEI Numbers
    98
    Registration Numbers
    98
    Unique Applicants
    19
    Years Active
    40

    Basic Information

    Product Code
    MBF
    Device Class
    FDA class 2
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 35 510(k) clearances via K numbers.

    K Number Device Name
    K250848 Identity Shoulder System
    K240876 Identity Shoulder System
    K233712 PRIMA Humeral System; PRIMA TT Glenoid
    K231099 SMR Hybrid Glenoid System
    K230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
    K231516 INHANCE™ Shoulder System, Sterile Single Use Instrumentation
    K223876 SMR Shoulder System
    K222427 PRIMA TT Glenoid
    K213856 Identity Shoulder System
    K212933 INHANCETM Hybrid Anatomic Glenoid Implant
    K220792 SMR Reverse Liner
    K202716 Ignite Anatomic Shoulder System
    K201905 SMR 140° Reverse Humeral Body
    K193038 Comprehensive Shoulder System
    K191963 SMR Finned Short Stems
    K183553 Compress and Mini Compress Anti-Rotation Spindles
    K173824 Humeral Short Stem System
    K163397 SMR Hybrid Glenoid System
    K162068 ARROW Anatomical Porous glenoid
    K140390 TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
    K130126 SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
    K123297 COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    K112905 COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    K083439 SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
    K081448 ENCORE SHOULDER REVISION GLENOID
    K070565 COFIELD TOTAL SHOULDER SYSTEM
    K063652 GLOBAL AP POROUS COATED HUMERAL STEM
    K060716 VERSA-DIAL HUMERAL HEAD PROSTHESIS
    K060692 COMPREHENSIVE PRIMARY SHOULDER STEMS
    K043100 BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
    K032895 BI-ANGULAR SHOULDER SYSTEM
    K010635 INTERLOK / HA COPELAND RESURFACING HEADS
    K011099 GLOBAL FX POROUS-COATED HUMERAL STEM
    K011047 GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
    K844415 POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS

    FEI Numbers

    This FDA classification entry is associated with 98 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 98 registration numbers. Click on an entry to view related FDA registrations.