510(k) Report

Devices descending from K002464

7 later devices reach Smith & Nephew Off-Centered Porp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc.20066—
+2K091187Grace Dynamic TorpGrace Medical, Inc.20090—
+2K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc.20064—
+3K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20133—
+4K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20132—
+5K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH20251—
+6K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…MED-EL Elektromedizinische Geräte GmbH20260—