Smith and Nephew Legion Hinge Knee System— 510(k) K151118

Name: FDA 510(k) clearance K151118
Creator: U.S. Food and Drug Administration
Published: 2015-07-28

Substantially Equivalent

Smith & Nephew

FDA 510(k) clearance K151118 for Smith and Nephew Legion Hinge Knee System, Substantially Equivalent on 2015-07-28. Applicant: Smith & Nephew. Device class: 2.

Clearance details

Applicant: Smith & Nephew
Product code: Product code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2015-04-27
Decision date: 2015-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

view all

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

More clearances from Smith & Nephew

view all

K241666 — EVOS Pelvic and Acetabular System2025-02-19
K240487 — EVOS Patella Plates2024-09-03
K233730 — Footprint Mini PK, 3.5mm Suture Anchor2024-01-17
K232457 — Q-FIX ULTRA All-Suture Anchor2023-09-08
K223762 — Smith & Nephew ACCORD Cable System2023-05-30

Adverse events under product code KRO

product code KRO

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.