Cleared Traditional

EVOLUTION? Cement Keel

K231947 · Microport Orthopedics, Inc. · Orthopedic
Oct 2023
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K231947 is an FDA 510(k) clearance for the EVOLUTION? Cement Keel, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on October 31, 2023, 123 days after receiving the submission on June 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K231947 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date October 31, 2023
Days to Decision 123 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

Similar Devices — JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 909
Materialise TKA Guide System
K253793 · Materialise NV · Jan 2026
EMPOWR Knee
K252974 · Encore Medical, L.P. · Dec 2025
ATTUNE? Total Knee System; ATTUNE? Revision Sleeve LPS? Femoral Adaptors
K253197 · Depuy Ireland UC · Nov 2025
Freedom Infinia? Total Knee System
K253314 · Maxx Orthopedics, Inc. · Oct 2025
Freedom? Total Knee System ? Titan PCK Components
K253144 · Maxx Orthopedics, Inc. · Oct 2025
Stem Extension Line (U2 Total Knee System?PSA Type)
K252725 · United Orthopedic Corporation · Sep 2025

More from Microport Orthopedics, Inc.

View all
NEXUS? Hip Stem
K250444 · LZO · May 2025
Evolution? Total Knee Systems - Kinematic Alignment Instrumentation and Technique
K243574 · JWH · Feb 2025
Ceramic Femoral Head
K240452 · LZO · Apr 2024
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 · KRO · Apr 2024
EVOLUTION? Tibial Cones
K233507 · MBH · Jan 2024