FDA.report

510(k) K241482

Device
Kinos Total Ankle System
Applicant
Restor3D
510(k) number
K241482
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-22
Date received
2024-05-24
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Brianna Prindle
Address
4001 Nc 54 Hwy. Suite 3160 Durham NC US 27709 27709

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code HSN

510(k)DeviceApplicantDecision date
K252454Kinos Total Ankle SystemRestor3D2025-09-03
K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)2025-06-20
K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2025-05-01
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
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