510(k) Report

Devices descending from K071032

21 later devices reach Arthrex Univers II Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+1K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+1K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+1K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+1K131633Arthrex Univers ApexArthrex, Inc.20134—
+1K103466Arthrex Univers II Shoulder ProsthesisArthrex, Inc.20105—
+1K083435Arthrex Univers II Shoulder Pegged GlenoidArthrex, Inc.20095—
+2K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+2K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+2K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+2K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+2K161108Arthrex VaultLock GlenoidArthrex, Inc.20163—
+2K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+2K120044Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-KeeledArthrex, Inc.20124—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K210050Augmented VaultLock GlenoidArthrex, Inc.20210—
+3K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—