Product code HSN— Orthopedic
APEX 3D Total Ankle Replacement System
- Classification name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Regulation
- 21 CFR 888.3110
- Advisory panel
- Orthopedic
- Total cleared
- 68
- First cleared
- Most recent
Market context for product code HSN
FDA has cleared devices under product code HSN between 1976 and 2026, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code HSN
Adverse events under product code HSN
product code HSN- Death
- 3
- Injury
- 4,711
- Total
- 4,714
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HSN
- K253159 — Prophecy Incompass Surgical Planning System
- K252454 — Kinos Total Ankle System
- K250037 — Incompass Total Ankle System
- K250641 — APEX 3D Total Ankle Replacement System
- K240475 — Hintermann Series H2 Total Ankle System
- K241999 — Prophecy Surgical Planning System
- K242868 — Kinos Total Ankle System
- K241482 — Kinos Total Ankle System
- K240259 — APEX 3D Total Ankle Replacement System
- K240591 — restor3d Kinos Axiom Total Ankle System
- K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System
- K232595 — Kinos Axiom Total Ankle System
- K230717 — Exactech® Vantage® Total Ankle System
- K232002 — Vantage® Total Ankle System
- K230462 — OPTIX H2 Patient Specific Instrument System
- K230313 — QUANTUM Patient Specific Instrumentation (PSI) System
- K222835 — Prophecy Preoperative Navigation Alignment System
- K223227 — MAVEN Patient-Specific Instrumentation
- K211883 — QUANTUM® Patient Specific Instrumentation (PSI) System
- K202815 — PROPHECY Preoperative Navigation Alignment System
- K210390 — Apex 3D Total Ankle Replacement System
- K202019 — Maven Patient-Specific Instrumentation
- K202373 — APEX 3D Total Ankle Replacement System
- K192994 — Paragon 28 APEX 3D Total Ankle Replacement System
- K192778 — Kinos Axiom Total Ankle System
- K201507 — Cadence Total Ankle System
- K193067 — The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System
- K191380 — Quantum® Total Ankle Prosthesis
- K191393 — INFINITY Total Ankle System, INBONE Total Ankle System
- K183343 — Vantage Total Ankle Flat Cut Talar Components
- K182878 — Integra Salto Total Ankle System
- K181557 — INFINITY Total Ankle System
- K180730 — INVISION Total Ankle Revision System
- K172633 — INFINITY Total Ankle System
- K171004 — Hintermann Series H2 Total Ankle System
- K171067 — INVISION Total Ankle Revision System
- K170968 — PROPHECY INVISION Pre-operative Navigation System
- K162795 — PROPHECY INVISION Preoperative Navigation Alignment System
- K153452 — Salto XT, Salto Talaris
- K153008 — INVISION Total Ankle Revision System
- K152217 — Exactech Vantage Total Ankle System
- K151459 — Integra Total Ankle Replacement System
- K142117 — INVISION TOTAL ANKLE REVISION SYSTEM
- K141740 — INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
- K140749 — INFINITY TOTAL ANKLE SYSTEM
- K133585 — INBONE TOTAL ANKLE
- K131283 — PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
- K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
- K123954 — INFINITY TOTAL ANKLE SYSTEM
- K123059 — INBONE ( I AND II) TOTAL ANKLE SYSTEMS
- K122395 — DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
- K120906 — ZIMMER TRABECULAR METAL TOTAL ANKLE
- K110360 — PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
- K103374 — INBONE TOTAL ANKLE SYSTEM MODEL 200347902
- K100886 — INBONE II TOTAL ANKLE REPLACEMENT
- K090076 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
- K061749 — ECLIPSE TOTAL ANKLE IMPLANT
- K060544 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
- K053569 — AGILITY LP TOTAL ANKLE PROSTHESIS
- K051023 — TOPEZ TOTAL ANKLE REPLACEMENT
- K020541 — AGILITY ANKLE REVISION PROSTHESIS
- K920802 — ALVINE TOTAL ANKLE
- K803167 — BRIGHAM TOTAL ANKLE PROSTHESIS
- K800530 — SCHLEIN TRI-SURFACE ANKLE
- K770420 — FORCEPS, ANKLE INSERTING, CON-AXIAL
- K770421 — COMPONENTS, ANKLE, TRIAL, CON-AXIAL
- K761020 — ANKLE (FREEMAN-SWANSON)
- K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON)
Data sourced from openFDA. This site is unofficial and independent of the FDA.