FDA.report

510(k) K242868

Device
Kinos Total Ankle System
Applicant
Restor3D
510(k) number
K242868
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-18
Date received
2024-09-20
Regulation
888.3110
Classification name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00840097532363Kinos Aeros Total Ankle Replacement Restor3d, Inc.2025-08-13
00840097515441Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097516097Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515335Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515328Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515311Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515304Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515298Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515281Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515274Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515267Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515250Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515052Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515045Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515038Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515021Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097515007Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514994Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514987Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514970Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514963Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514956Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097514949Kinos Aeros Total Ankle Replacement Restor3d, Inc.2025-05-01
00840097514932Kinos Aeros Total Ankle Replacement Restor3d, Inc.2025-05-01
00840097514925Kinos Aeros Total Ankle Replacement Restor3d, Inc.2025-05-01
00840097516219Kinos Aeros Total Ankle ReplacementRestor3d, Inc.2025-05-01
00840097516332Kinos Aeros Instrumentation Restor3d, Inc.2025-05-01
00840097516325Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097516318Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01
00840097516301Kinos Aeros InstrumentationRestor3d, Inc.2025-05-01

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
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