Cleared Traditional

ATTUNE? Revision Hinge Knee

K242871 · Depuy Ireland UC · Orthopedic
Nov 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K242871 is an FDA 510(k) clearance for the ATTUNE? Revision Hinge Knee, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on November 21, 2024, 59 days after receiving the submission on September 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K242871 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date November 21, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

Similar Devices — KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 85
Triathlon? Tritanium? Asymmetric Patella; Triathlon? Tritanium? Symmetric Patella; Triathlon? Symmetric Patella; Triathlon? Asymmetric Patella; Scorpio? Universal Dome Patella; Triathlon? Hinge Bumper
K252898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2025
Stem Extension Line (USTAR II System)
K252303 · United Orthopedic Corporation · Aug 2025
Triathlon? Hinge Knee System
K251665 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2025
EVOLUTION? Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION? MP Total Knee System; EVOLUTION? MP Total Knee System; EVOLUTION? MP Adaptive CS Insert; EVOLUTION? MP Adaptive PS Tibial Insert; EVOLUTION? MP CS/CR Porous Femur/EVOLUTION? Adaptive CS and PS Inserts; EVOLUTION? Revision CCK System; ADVANCE? Double High Insert; ADVANCE? A-CLASS? Tibial Insert; ADVANCE? Knee System; ADVANCE? Ultra-Congruent Tibial Inse
K240043 · Microport Orthopedics, Inc. · Apr 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K233980 · Depuy Ireland UC · Mar 2024
EVOLUTION? Hinge Knee System
K230563 · Microport Orthopedics, Inc. · Sep 2023