510(k) Report

Devices descending from K043547

11 later devices reach Compress Segmental Femoral Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp20101—
+1K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc.20082—
+1K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp20071021
+2K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+2K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+2K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+3K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501