510(k) Report

Devices descending from K192074

9 later devices reach Signature ONE System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+2K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+3K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+3K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—