FDA.reportPublic FDA data

510(k) K191433

Device
AGILON® XO Shoulder Replacement System
Applicant
Implantcast GmbH
510(k) number
K191433
Product code
HSD
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-12
Date received
2019-05-29
Regulation
888.3690
Classification name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Juliane Hoppner
Address
Lueneburger Schanze 26 Buxtehude DE 21614 21614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233260Univers Revers CA Head and AdapterArthrex, Inc.2024-02-12
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K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC2020-05-15
K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.2018-04-18
K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2016-11-21
K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH2016-11-01
K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc.2016-04-19
K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.2014-12-19
K131298EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMExactech, Inc.2013-11-26
K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMFx Solutions2013-11-09
K130675ARTHREX UNIVERS II CA HEADSArthrex, Inc.2013-10-30
K130635SEVIIN SURFACE REPLACEMENT SHOULDERIngen Orthopedics, LLC2013-08-26
K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSmith & Nephew, Inc.2012-09-07
K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSLima Corporate S.P.A.2012-06-01
K112983SPACER-STecres S.P.A.2011-12-12