510(k) Report

Devices descending from K032522

27 later devices reach Tecres Spacer-K Temporary Knee Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222570COPAL knee mouldsHeraeus Medical GmbH20231—
+1K062274Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Tecres S.P.A.200820—
+1K050210Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc.2005248
+2K243024Cellbrick Knee SpacerUnited Orthopedic Corporation20240—
+2K190216SpaceFlex KneeG21, S.R.L.20191—
+2K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A.20191—
+2K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc.201738
+2K133449Kasm Knee Articulating Spacer MoldsOrtho Development Corp.20140—
+2K101356Spacer-G and Spacer-KTecres S.P.A.201119—
+3K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+3K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.20220—
+3K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.20200—
+3K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH20191—
+3K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC201216—
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20251—
+4K220492COPAL exchange G hip spacerHeraeus Medical GmbH20220—
+4K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC20202—
+4K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC20195—
+4K173967Remedy Acetabular CupOsteoremedies, LLC20185—
+5K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+5K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC20240—
+5K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+5K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC20231—
+5K191981REMEDY Acetabular CupOsteoremedies, LLC20194—
+6K223441SpaceFlex Acetabular CupG21, S.R.L.20230—