Stryker Orthopaedics - FDA 510(k) Cleared Devices
Recent clearances: Insignia Hip Stem, EXETER Centralizer, EXETER 2.5mm Plug, Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Orthopaedics Orthopedic ✕
24 devices
Cleared
Aug 16, 2021
Insignia Hip Stem
Orthopedic
74d
Cleared
Aug 28, 2019
EXETER Centralizer, EXETER 2.5mm Plug
Orthopedic
92d
Cleared
Mar 19, 2018
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Orthopedic
126d
Cleared
Feb 02, 2018
Triathlon Total Knee System
Orthopedic
45d
Cleared
Oct 30, 2017
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Orthopedic
90d
Cleared
May 25, 2016
Stryker Orthopaedics Hip Systems Labeling Update
Orthopedic
188d
Cleared
Aug 10, 2015
Restoration Anatomic Shell
Orthopedic
89d
Cleared
Feb 09, 2015
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip...
Orthopedic
105d
Cleared
Jan 13, 2015
Triathlon Tritanium Cone Augments
Orthopedic
48d
Cleared
Nov 14, 2014
Restoration Anatomic Shell
Orthopedic
73d
Cleared
Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
Orthopedic
103d
Cleared
Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
Orthopedic
96d