Implantcast GmbH - FDA 510(k) Cleared Devices
Recent clearances: EPORE® XO cup system, implaFit® short stems, AGILON® XO Shoulder Replacement System
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Implantcast GmbH Orthopedic ✕
19 devices
Cleared
Apr 24, 2026
EPORE® XO cup system
Orthopedic
263d
Cleared
Mar 12, 2026
implaFit® short stems
Orthopedic
224d
Cleared
Mar 10, 2025
AGILON® XO Shoulder Replacement System
Orthopedic
251d
Cleared
Oct 24, 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
Orthopedic
259d
Cleared
Sep 06, 2024
ACS® LD FB Knee System
Orthopedic
260d
Cleared
Jun 03, 2024
EcoFit® short stem cementless cpTi
Orthopedic
69d
Cleared
Feb 16, 2024
AGILON® XO Shoulder Replacement System
Orthopedic
254d
Cleared
Oct 19, 2023
Actinia® hip stems
Orthopedic
72d
Cleared
Jun 20, 2023
BethaLoc® stem cementless HA
Orthopedic
263d
Cleared
Sep 28, 2022
AGILON XO Shoulder System
Orthopedic
42d
Cleared
Aug 17, 2022
implaFit® hip stems
Orthopedic
530d
Cleared
Feb 03, 2021
EcoFit® Hip System
Orthopedic
76d