510(k) Report

Devices descending from K993836

28 later devices reach Generation 4 Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051496Cobalt Bone CementBiomet, Inc.200534
+1K051532Cobalt G HV Bone CementBiomet, Inc.200523—
+2K092150Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone CementBiomet, Inc.20091—
+2K091608Cobalt MV Bone CementBiomet Manufacturing Corp200912
+2K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A.200820—
+2K070015Cobalt V Radiopaque Vertebroplasty Bone CementBiomet Manufacturing Corp20070—
+3K192394Hi-Fatigue Bone CementOsartis GmbH20190—
+3K192379Hi-Fatigue G Bone CementOsartis GmbH20190—
+3K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+4K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+4K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+4K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+5K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+5K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+5K190216SpaceFlex KneeG21, S.R.L.20191—
+5K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+6K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+6K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+6K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+6K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+6K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+6K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+6K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+7K223441SpaceFlex Acetabular CupG21, S.R.L.20230—