BEUDAMED
    Product Code: HSD FDA class 2 21 CFR 888.3690

    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    Orthopedic

    An uncemented metallic humeral hemi-shoulder prosthesis is an implant used to replace only the humeral head of the shoulder joint, relying on bone ingrowth rather than cement for fixation, typically in cases of proximal humeral fracture or avascular necrosis. It is classified as an FDA Class 2 device under 21 CFR 888.3690, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSD falls under the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    71
    FEI Numbers
    230
    Registration Numbers
    230
    Unique Applicants
    44
    Years Active
    44

    Basic Information

    Product Code
    HSD
    Device Class
    FDA class 2
    Regulation Number
    888.3690
    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 71 510(k) clearances via K numbers.

    K Number Device Name
    K233260 Univers Revers CA Head and Adapter
    K221232 Univers Revers Humeral Cup Implant
    K191433 AGILON® XO Shoulder Replacement System
    K193122 Biocore9 Humeral Resurfacing System
    K173964 OVOMotion Shoulder Arthroplasty System
    K161782 Arthrex Univers Revers Shoulder Prosthesis System
    K161620 Anatomical Shoulder Domelock Dome centric
    K151527 Arthrex Univers Revers CA Heads and Adapters
    K142942 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
    K131298 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
    K130759 HUMELOCK II CEMENTLESS SHOULDER SYSTEM
    K130675 ARTHREX UNIVERS II CA HEADS
    K130635 SEVIIN SURFACE REPLACEMENT SHOULDER
    K121714 SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
    K112900 SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
    K112983 SPACER-S
    K111097 HUMELOCK CEMENTED SHOULDER PROSTHESIS
    K082715 DEPUY GLOBAL AP CTA HUMERAL HEAD
    K080990 DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
    K073331 DVO EXTENDED ARTICULATION HUMERAL HEADS
    K072578 SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
    K071064 ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
    K070963 REUNION HA FRACTURE STEM
    K063578 PROMOS MODULAR SHOULDER SYSTEM
    K062661 AEQUALIS RESURFACING HEAD
    K062845 MODULAR REPLACEMENT ELBOW SYSTEM
    K063081 AEQUALIS SHOULDER SYSTEM
    K062861 ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
    K061862 AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
    K061677 SOLAR PUREFIX HA SHOULDER
    K061454 EXACTECH EQUINOXE SHOULDER STEMS
    K060535 SPACER-S TEMPORARY SHOULDER SPACER
    K051843 COPELAND EAS HUMERAL RESURFACING HEADS
    K040432 SOLAR 2 ANATOMIC SHOULDER
    K040128 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
    K032126 PROMOS SHOULDER
    K033516 DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
    K031971 GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
    K032264 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
    K023096 CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
    K012377 OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
    K010827 COPELAND MB/HA RESURFACING HUMERAL HEADS
    K010657 COPELAND MB RESURFACING HUMERAL HEADS
    K011942 AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
    K010664 COPELAND RESURFACING HUMERAL HEADS
    K003044 COPELAND RESURFACING HEADS
    K003428 ISS OFFSET HEADS
    K001419 SOLAR SHOULDER OFFSET HUMERAL HEAD
    K992525 ACUMED MODULAR SHOULDER SYSTEM
    K992394 BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
    K984202 HOWMEDICA HUMERAL INTERCALARY SYSTEM
    K982886 OTI MODULAR SHOULDER SYSTEM
    K961260 KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
    K962289 SELECT SHOULDER COCR HUMERAL STEM COMPONENT
    K954559 HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
    K943908 INFINITY SHOULDER SYSTEM
    K950594 HEMI-SHOULDER PROSTHESIS
    K935593 ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
    K913282 LIMA RPS SHOULDER
    K911982 BONE NAIL, KUNTSCHER
    K911686 GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
    K911902 TEMPERLITE(TM) SAW BLADE
    K905580 TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
    K905577 EXACTECH HUMERAL SHOULDER PROSTHESIS
    K874643 KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
    K873679 SELECT SHOULDER SYSTEM
    K873073 KIRSCHNER NEER-III PROXIMAL HUMERUS
    K822771 101 NEER TYPE SHOULDER
    K802123 MONOSPHERICAL SHOULDER PROSTHESIS
    K800494 NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
    K791548 REXTON HS(HEARING SYSTEM)

    FEI Numbers

    This FDA classification entry is associated with 230 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 230 registration numbers. Click on an entry to view related FDA registrations.