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Howmedica Osteonics Corp., Dba Stryker Orthopaedics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertFebruary 18, 2026
K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® SymmetDecember 15, 2025
K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsOctober 24, 2025
K251665Triathlon® Hinge Knee SystemJuly 25, 2025
K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized TFebruary 6, 2025
K243784Stryker Orthopaedics Hip Devices Labeling UpdateFebruary 6, 2025
K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium TiDecember 4, 2024
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentAugust 2, 2024
K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsApril 24, 2024
K240418Stryker Orthopaedics Hip Systems Labeling UpdateApril 12, 2024
K23372428mm/38D MDM X3 Insert for MDM LinerMarch 11, 2024
K233498Stryker Orthopaedics Hip Systems Labeling UpdateDecember 21, 2023
K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentJune 2, 2023
K223069Modular Rotating Hinge Knee Systems and Compatible ComponentsApril 21, 2023
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJanuary 26, 2023
K223528Triathlon® Hinge Knee SystemJanuary 20, 2023
K222632UHR Bipolar Implants, Restoration GAP II ImplantsOctober 21, 2022
K220376Acetabular Dome Hole PlugMarch 9, 2022
K212187Restoration® Modular Hip SystemMarch 1, 2022
K213701Exeter® X3® RimFit® CupFebruary 1, 2022