510(k) Report

Devices descending from K002757

62 later devices reach Oncology Salvage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190100USTAR II SystemUnited Orthopedic Corporation201925
+1K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.20143—
+1K123501Oss Modular Stems, Oss Diaphyseal SegmentsBiomet, Inc.20136—
+1K121056Mets Modular Proximal FemurStanmore Implants Worldwide, Ltd.20120—
+1K121029Mets Modular Distal FemurStanmore Implants Worldwide, Ltd.20123—
+1K121055Mets Modular Total FemurStanmore Implants Worldwide, Ltd.20123—
+1K083779Mak Oss Knee Femoral ComponentsBiomet Manufacturing Corp200911
+1K083827Orthopedic Salvage System (Oss) 9CM Cobalt - Chrome Tibial BodiesBiomet Manufacturing Corp200901
+1K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc.20082—
+1K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc.200619—
+1K052685Orthopedic Salvage System- OssBiomet, Inc.2005112
+1K051479RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsBiomet Manufacturing, Inc.20056—
+1K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.2005116
+1K051570Avl Hinge Knee SystemBiomet, Inc.20054—
+1K042409Modular Arthrodesis NailBiomet, Inc.200402
+1K041352Compress Distal Femoral Replacement SystemBiomet, Inc.200412—
+1K033871IM Total FemurBiomet, Inc.20041—
+1K021260Reduced Size Oncology Salvage SystemBiomet, Inc.20027—
+1K021380Oss Les Proximal Femoral ComponentBiomet, Inc.20022—
+1K020381Expandable KneeBiomet Orthopedics, Inc.200232
+1K020970Modification to Oncology Salvage System (Oss)Biomet, Inc.20020—
+2K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+2K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.20260—
+2K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+2K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+2K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+2K140898Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd.201502
+2K140509Biomet Side Access Distal Femoral ExpandableBiomet Manufacturing, LLC20141—
+2K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd.201421
+2K131393Mak Oss Femoral Knee ComponentsBiomet Orthopedics Corp.20130—
+2K122015Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…Howmedica Osteonics Corp.20130—
+2K120992Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd.201236
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp20101—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K072336Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp20074—
+2K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp20071021
+2K060131Oss-Bodies Proximal Tibial SleeveBiomet Manufacturing Corp20060—
+3K233507EVOLUTION® Tibial ConesMicroport Orthopedics, Inc.20240—
+3K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+3K1701493DMetal Tibial ConesMedacta International S.A.20170—
+3K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+3K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd.20150—
+3K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+3K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K153437Apex Revision Knee SystemOmnilife Science201541
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+7K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+8K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+8K201611Apex Knee SystemOmnilife Science20210—