510(k) Report

Devices descending from K101356

19 later devices reach Spacer-G and Spacer-K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+1K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+1K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+2K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+2K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+2K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+2K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+2K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+2K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+2K190216SpaceFlex KneeG21, S.R.L.20191—
+2K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+3K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+3K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+3K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+3K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+3K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+3K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+4K223441SpaceFlex Acetabular CupG21, S.R.L.20230—