FDA Product Code HSN: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Total ankle replacement has gained significant momentum as an alternative to arthrodesis. FDA product code HSN covers semi-constrained cemented ankle prostheses with metal-polymer bearing surfaces.
These three-component implants replace the tibial plafond and talar dome surfaces to restore pain-free ankle motion while preserving the natural kinematics of the joint. They offer improved gait compared to ankle fusion in appropriately selected patients with end-stage ankle arthritis.
HSN devices are Class II medical devices, regulated under 21 CFR 888.3110 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Wrightmedicaltechnologyinc, Paragon 28, Inc. and Restor3d.
69
Total
69
Cleared
132d
Avg days
1976
Since
Declining activity -
6 submissions in the last 2 years
vs 13 in the prior period
Review times increasing: avg
165d
recently vs 129d historically
FDA 510(k) Cleared Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer Devices (Product Code HSN)
69 devices
Cleared
Oct 07, 2026
APEX 3D S Diamond Tibia
Paragon 28, Inc.
Orthopedic
187d
Cleared
Jun 16, 2026
Prophecy Incompass Surgical Planning System
Wright Medical Technology, Inc. (Stryker)
Orthopedic
263d
Cleared
Sep 03, 2025
Kinos Total Ankle System
Restor3d
Orthopedic
30d
Cleared
Jun 20, 2025
Incompass Total Ankle System
Wright Medical Technology, Inc. (Stryker)
Orthopedic
163d
Cleared
May 01, 2025
APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
Orthopedic
58d
Cleared
Dec 02, 2024
Hintermann Series H2 Total Ankle System
Vilex, LLC
Orthopedic
286d
Cleared
Nov 01, 2024
Prophecy Surgical Planning System
Wright Medical Technology, Inc. (Stryker)
Orthopedic
115d
Cleared
Oct 18, 2024
Kinos Total Ankle System
Restor3d
Orthopedic
28d
Cleared
Jul 22, 2024
Kinos Total Ankle System
Restor3d
Orthopedic
59d
Cleared
Jun 24, 2024
APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
Orthopedic
145d
Cleared
Apr 29, 2024
restor3d Kinos Axiom Total Ankle System
Restor3D, Inc.
Orthopedic
59d
Cleared
Apr 23, 2024
QUANTUM® Patient Specific Instrumentation (PSI) System
In2bones Sas
Orthopedic
316d
Cleared
Nov 28, 2023
Kinos Axiom Total Ankle System
Restor3d
Orthopedic
95d
Cleared
Oct 12, 2023
Exactech® Vantage® Total Ankle System
Exactech, Inc.
Orthopedic
211d
Cleared
Sep 11, 2023
Vantage® Total Ankle System
Exactech, Inc.
Orthopedic
68d
Cleared
Jul 17, 2023
OPTIX H2 Patient Specific Instrument System
Vilex, LLC
Orthopedic
146d
Cleared
Apr 06, 2023
QUANTUM Patient Specific Instrumentation (PSI) System
In2bones Sas
Orthopedic
59d
Cleared
Jan 27, 2023
Prophecy Preoperative Navigation Alignment System
Wrightmedicaltechnologyinc
Orthopedic
129d
Cleared
Nov 17, 2022
MAVEN™ Patient-Specific Instrumentation
Paragon 28, Inc.
Orthopedic
30d
Cleared
Aug 11, 2021
QUANTUM® Patient Specific Instrumentation (PSI) System
In2bones Sas
Orthopedic
51d
Cleared
Mar 10, 2021
PROPHECY Preoperative Navigation Alignment System
Wrightmedicaltechnologyinc
Orthopedic
167d
Cleared
Mar 06, 2021
Apex 3D Total Ankle Replacement System
Paragon 28, Inc.
Orthopedic
25d
Cleared
Jan 14, 2021
Maven Patient-Specific Instrumentation
Paragon 28, Inc.
Orthopedic
177d
Cleared
Nov 13, 2020
APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
Orthopedic
86d
About Product Code HSN - Regulatory Context
510(k) Submission Activity
69 total 510(k) submissions under product code HSN since 1976, with 69 receiving FDA clearance (average review time: 132 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 13 in the prior period.
FDA 510(k) Review Time - HSN Product Code
Recent submissions under HSN have taken an average of 165 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
HSN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →