HSN · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Orthopedic · 21 CFR 888.3110 · Class 2

Overview

Product CodeHSN
Device NameProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation21 CFR 888.3110
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Recent Cleared Devices (20 of 67)

Showing 20 most recent of 67 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252454Kinos Total Ankle SystemRestor3DSep 3, 2025SESE
K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)Jun 20, 2025SESE
K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.May 1, 2025SESE
K240475Hintermann Series H2 Total Ankle SystemVilex, LLCDec 2, 2024SESE
K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)Nov 1, 2024SESE
K242868Kinos Total Ankle SystemRestor3DOct 18, 2024SESE
K241482Kinos Total Ankle SystemRestor3DJul 22, 2024SESE
K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.Jun 24, 2024SESE
K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.Apr 29, 2024SESE
K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones SasApr 23, 2024SESE
K232595Kinos Axiom Total Ankle SystemRestor3DNov 28, 2023SESE
K230717Exactech® Vantage® Total Ankle SystemExactech, Inc.Oct 12, 2023SESE
K232002Vantage® Total Ankle SystemExactech, Inc.Sep 11, 2023SESE
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLCJul 17, 2023SESE
K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones SasApr 6, 2023SESE
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyincJan 27, 2023SESE
K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.Nov 17, 2022SESE
K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones SasAug 11, 2021SESE
K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyincMar 10, 2021SESE
K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.Mar 6, 2021SESE

Top Applicants

Innolitics

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