Revolution Radial Head

FDA 510(k) K183618 · Ignite Orthopedics, Inc.

Substantially Equivalent

510(k) numberK183618

Submission

Device name
Revolution Radial Head
Applicant
Ignite Orthopedics, Inc.
Warsaw, IN, US
Received
December 26, 2018
Decision date
May 17, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3170
Specialty
Orthopedic
Implant
Yes

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K212872Avenger Radial Head SystemKWI · Traditional In2bones USA, LLC12/17/2021SE
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K172688Align Radial Head SystemKWI · Special Skeletal Dynamics, LLC12/22/2017SE
K132735Axia Radial Head SystemKWI · Traditional Imds (Innovative MEdical Device Systems) - Leis ME01/07/2014SE
K131845Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh…KWI · Traditional Acumed, LLC09/30/2013SE
K112030Synthes Radial Head Prosthesis SystemKWI · Traditional Synthes USA, LLC06/19/2012SE

More from Synthes USA, LLC

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Questions and answers

When was Revolution Radial Head cleared by the FDA?

Revolution Radial Head (K183618) received a 510(k) decision of Substantially Equivalent on May 17, 2019, 142 days after the submission was received.

What is the product code of K183618?

The FDA product code is KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3170.