EVOLUTION® Hinge Knee System +13 more— 510(k) K240043

Clearance details

Device name as filed

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

Applicant

Microport Orthopedics, Inc.

Product code

Code KRO

Device class

Class 2

Regulation

21 CFR 888.3510

Advisory panel

Orthopedic

Date received

2024-01-05

Decision date

2024-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arlington, TN, US

• K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
• K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
• K252303 — Stem Extension Line (USTAR II System)2025-08-22
• K251665 — Triathlon® Hinge Knee System2025-07-25
• K242871 — ATTUNE Revision Hinge Knee2024-11-21

• K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
• K250444 — NEXUS® Hip Stem2025-05-15
• K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique2025-02-18
• K240452 — Ceramic Femoral Head2024-04-12
• K233507 — EVOLUTION® Tibial Cones2024-01-18

Death

19

Injury

4,841

Total

4,860

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →