510(k) Report

Devices descending from K212560

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

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