FDA.reportPublic FDA data

510(k) K250641

Device
APEX 3D Total Ankle Replacement System
Applicant
Paragon 28, Inc.
510(k) number
K250641
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-01
Date received
2025-03-04
Regulation
888.3110
Classification name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Edward Wells-Spicer
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HSN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252454Kinos Total Ankle SystemRestor3D2025-09-03
K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)2025-06-20
K240475Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-02
K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)2024-11-01
K242868Kinos Total Ankle SystemRestor3D2024-10-18
K241482Kinos Total Ankle SystemRestor3D2024-07-22
K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2024-06-24
K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.2024-04-29
K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas2024-04-23
K232595Kinos Axiom Total Ankle SystemRestor3D2023-11-28
K230717Exactech® Vantage® Total Ankle SystemExactech, Inc.2023-10-12
K232002Vantage® Total Ankle SystemExactech, Inc.2023-09-11
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC2023-07-17
K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas2023-04-06
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2023-01-27