Stryker Orthopaedics

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1915-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024
Z-1911-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024
Z-1912-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024
Z-1914-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024
Z-1913-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024
Z-1910-2024Class IITotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3April 15, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K211703Insignia Hip StemAugust 16, 2021
K191414EXETER Centralizer, EXETER 2.5mm PlugAugust 28, 2019
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsMarch 19, 2018
K173849Triathlon Total Knee SystemFebruary 2, 2018
K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemOctober 30, 2017
K153345Stryker Orthopaedics Hip Systems Labeling UpdateMay 25, 2016
K151264Restoration Anatomic ShellAugust 10, 2015
K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the DirFebruary 9, 2015
K143393Triathlon Tritanium Cone AugmentsJanuary 13, 2015
K142462Restoration Anatomic ShellNovember 14, 2014
K141056TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSAugust 5, 2014
K132624TRIATHLON TRITANIUM METAL-BACKED PATELLANovember 26, 2013
K072575TRIATHLON SCREW-FIXATION TIBIAL BASEPLATEJanuary 7, 2008
K070170DALL-MILES SYSTEMMarch 2, 2007
K063816PCA ALUMINA FEMORAL HEADSFebruary 2, 2007
K063822MODIFICATION TO HIPSTAR FEMORAL STEMJanuary 25, 2007
K062553SIMPLEX P BONE CEMENTJanuary 8, 2007
K051223HIPSTAR FEMORAL STEMMay 10, 2006
K053514TRIATHLON TOTAL KNEE SYSTEMJanuary 26, 2006
K053528SHORT CITATION FEMORAL STEMJanuary 13, 2006