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HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
HSN
Device Class
Class II
Regulation Number
888.3110
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252454restor3dKinos Total Ankle SystemSeptember 3, 2025
K250037wright medical technology, inc. (stryker)Incompass Total Ankle SystemJune 20, 2025
K250641paragon 28APEX 3D Total Ankle Replacement SystemMay 1, 2025
K240475vilexHintermann Series H2 Total Ankle SystemDecember 2, 2024
K241999wright medical technology, inc. (stryker)Prophecy Surgical Planning SystemNovember 1, 2024
K242868restor3dKinos Total Ankle SystemOctober 18, 2024
K241482restor3dKinos Total Ankle SystemJuly 22, 2024
K240259paragon 28APEX 3D Total Ankle Replacement SystemJune 24, 2024
K240591restor3drestor3d Kinos Axiom Total Ankle SystemApril 29, 2024
K231699in2bonesQUANTUM® Patient Specific Instrumentation (PSI) SystemApril 23, 2024
K232595restor3dKinos Axiom Total Ankle SystemNovember 28, 2023
K230717exactechExactech® Vantage® Total Ankle SystemOctober 12, 2023
K232002exactechVantage® Total Ankle SystemSeptember 11, 2023
K230462vilexOPTIX H2 Patient Specific Instrument SystemJuly 17, 2023
K230313in2bonesQUANTUM Patient Specific Instrumentation (PSI) SystemApril 6, 2023
K222835wrightmedicaltechnologyincProphecy Preoperative Navigation Alignment SystemJanuary 27, 2023
K223227paragon 28MAVEN™ Patient-Specific InstrumentationNovember 17, 2022
K211883in2bonesQUANTUM® Patient Specific Instrumentation (PSI) SystemAugust 11, 2021
K202815wrightmedicaltechnologyincPROPHECY Preoperative Navigation Alignment SystemMarch 10, 2021
K210390paragon 28Apex 3D Total Ankle Replacement SystemMarch 6, 2021