Ignite Anatomic Shoulder System

FDA 510(k) K202716 · Ignite Orthopedics, LLC

Substantially Equivalent

510(k) numberK202716

Submission

Device name
Ignite Anatomic Shoulder System
Applicant
Ignite Orthopedics, LLC
Winona Lake, IN, US
Received
September 17, 2020
Decision date
May 20, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3670
Specialty
Orthopedic
Implant
Yes

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K250848Identity Shoulder SystemMBF · Traditional Zimmer, Inc.07/02/2025SE
K240876Identity Shoulder SystemMBF · Traditional Zimmer, Inc.06/12/2024SE
K233712PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional Lima Corporate S.P.A.01/11/2024SE
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K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBF · Traditional Depuy Ireland UC11/13/2023SE
K231516INHANCE™ Shoulder System, Sterile Single Use InstrumentationMBF · Traditional Depuy Ireland UC07/21/2023SE
K223876SMR Shoulder SystemMBF · Traditional Lima Corporate S.P.A.02/03/2023SE
K222427PRIMA TT GlenoidMBF · Traditional Lima Corporate S.P.A.10/06/2022SE

More from Lima Corporate S.P.A.

510(k)DeviceDecision
K203108Ignite Stemless Anatomic Shoulder SystemPKC · Traditional 07/16/2021SE
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Questions and answers

When was Ignite Anatomic Shoulder System cleared by the FDA?

Ignite Anatomic Shoulder System (K202716) received a 510(k) decision of Substantially Equivalent on May 20, 2021, 245 days after the submission was received.

What is the product code of K202716?

The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.