Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tendon Anchor, Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue, LANDMARK Total Knee System
535
Total
521
Cleared
1
Denied
FDA 510(k) Regulatory Record - Smith & Nephew, Inc. Orthopedic ✕
380 devices
Cleared
Oct 23, 2026
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue
Orthopedic
30d
Cleared
Sep 08, 2026
LANDMARK Total Knee System
Orthopedic
127d
Cleared
Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
Orthopedic
28d
Not Cleared
Jul 06, 2026
TESSA Spatial Surgery System
Orthopedic
318d
Cleared
Apr 06, 2026
AETOS Shoulder System - CONCELOC Glenoids
Orthopedic
109d
Cleared
Oct 29, 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
Orthopedic
89d
Cleared
Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
Orthopedic
88d
Cleared
Jun 25, 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)
Orthopedic
28d
Cleared
Jun 12, 2025
TRIGEN Stable Lock Nut & Washer
Orthopedic
202d
Cleared
Apr 02, 2025
LEGION Total Knee System
Orthopedic
27d
Cleared
Mar 28, 2025
CATALYSTEM Femoral Stems
Orthopedic
30d
Cleared
Dec 09, 2024
TRIGEN META-TAN Trochanteric Antegrade Nail
Orthopedic
41d
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