510(k) Report

Devices descending from K031841

32 later devices reach Spacer G Temporary Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252326InterSpace GV Hip SpacerTecres S.P.A.20250—
+1K192041G21 SpaceFlex HipG21, S.R.L.20190—
+1K080979Stageone Select Cement Spacer Molds for Temporary Hip ReplacementBiomet Manufacturing Corp2008315
+1K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A.200820—
+1K052990Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement…Biomet, Inc.2005305
+2K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc.2016215
+2K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+2K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+3K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.20220—
+3K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+3K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+3K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+3K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+4K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+4K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+4K190216SpaceFlex KneeG21, S.R.L.20191—
+4K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+5K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+5K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+5K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+5K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+5K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+6K223441SpaceFlex Acetabular CupG21, S.R.L.20230—