510(k) Report

Devices descending from K061454

16 later devices reach Exactech Equinoxe Shoulder Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+1K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+1K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—