510(k) Report

Devices descending from K122296

8 later devices reach SL-Plus Mia Femoral Stems with TI/HA Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc.20153—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K170473C2 femoral stemLima Corporate S.P.A.20170—