510(k) Report

Devices descending from K031804

13 later devices reach Compress Distal Femoral Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.2005116
+1K041352Compress Distal Femoral Replacement SystemBiomet, Inc.200412—
+2K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp20101—
+2K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc.20082—
+2K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp20071021
+3K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501