510(k) Report

Devices descending from K051977

72 later devices reach Scorpio Knee System Tibial Inserts and Patellar Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+1K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+1K110362Vanguard Asymmetrical Patellar ComponentBiomet Manufacturing Corp20117—
+1K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.200915—
+2K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260—
+2K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+2K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+2K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+2K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+2K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+2K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+2K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+2K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+2K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+2K161414Anatomic Total Knee SystemAmplitude20171—
+2K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+2K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+2K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+2K140902E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series…Biomet, Inc.20146—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+2K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+2K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.20097—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+3K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K230078TRAX® CR Total Knee SystemAmplitude20230—
+3K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+3K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+3K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+3K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+3K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+3K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+3K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+4K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101