510(k) Report

Devices descending from K030978

45 later devices reach Scorpio NRG Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+1K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202522
+1K161414Anatomic Total Knee SystemAmplitude20171—
+1K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+1K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+1K110404Eaum Total Knee SystemCorentec Co., Ltd.2012142
+1K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.200915—
+1K071991Modification to Scorpio NRG Knee SystemHowmedica Osteonics Corp.200729—
+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—
+2K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+2K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+2K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+2K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+2K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K192084Madison Total Knee SystemImplanet, S.A.20190—
+2K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+2K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+2K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+2K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+2K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+2K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.20097—
+3K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+3K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+3K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+3K181146ASK SystemL and K Biomed Corporation Limited20180—
+3K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—