510(k) Report

Devices descending from K140063

10 later devices reach Equinoxe Extra Short Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+2K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—