Cleared Traditional

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

K241716 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Aug 2024
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K241716 is an FDA 510(k) clearance for the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on August 2, 2024, 49 days after receiving the submission on June 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K241716 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2024
Decision Date August 02, 2024
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

Similar Devices — JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 561
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
K243571 · Zimmer Biomet · Jul 2025
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
K240783 · Smith & Nephew, Inc. · Oct 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024
Global Modular Replacement System
K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Dec 2023
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K222056 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jan 2023
C-Stem AMT LE Prosthesis
K220216 · Depuy Ireland UC · Jul 2022

More from Howmedica Osteonics Corp.,...

View all
Triathlon? Total Knee System - Triathlon? X3? Medial Stabilized Tibial Bearing Insert
K253637 · MBH · Feb 2026
Triathlon? Tritanium? Asymmetric Patella; Triathlon? Tritanium? Symmetric Patella; Triathlon? Symmetric Patella; Triathlon? Asymmetric Patella; Scorpio? Universal Dome Patella; Triathlon? Hinge Bumper
K252898 · KRO · Dec 2025
Triathlon? Total Knee System - Triathlon? Gold Femoral Components
K252044 · MBH · Oct 2025
Stryker and Serf hip devices
K250989 · LPH · Jul 2025
Triathlon? Hinge Knee System
K251665 · KRO · Jul 2025