Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981), AETOS Shoulder System - CONCELOC Glenoids, AETOS Shoulder System Meta Humeral Prosthesis Size 0
532
Total
518
Cleared
1
Denied
FDA 510(k) Regulatory Record - Smith & Nephew, Inc. Orthopedic ✕
378 devices
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
Cleared
Nov 20, 2024
AETOS Shoulder System Stemless Humeral Prosthesis
Orthopedic
250d
Cleared
Oct 30, 2024
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
Orthopedic
51d
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