510(k) Report

Devices descending from K910990

25 later devices reach Osteonics 7000 Series Total Knee Tibial Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032829Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp.200323—
+1K020703Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray CoatingHowmedica Osteonics Corp.20020—
+2K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.200915—
+2K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+3K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260—
+3K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+3K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+3K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+3K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+3K161414Anatomic Total Knee SystemAmplitude20171—
+3K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+3K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+3K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.20097—
+3K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+4K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+4K131167UnivationAesculap Implant Systems, LLC201308
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+5K201611Apex Knee SystemOmnilife Science20210—