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FDA 510(k)

Ignite Anatomic Shoulder System

K-Number: K202716 · 2021-05-20

ApplicantIgnite Orthopedics, LLC
Decision Date2021-05-20
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ignite Anatomic Shoulder System is a medical device manufactured by Ignite Orthopedics, LLC. It received FDA 510(k) clearance on 2021-05-20 under approval number K202716. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ignite Anatomic Shoulder System?

Ignite Anatomic Shoulder System is a medical device that received FDA 510(k) clearance on 2021-05-20. It is manufactured by Ignite Orthopedics, LLC. The 510(k) number is K202716.

When was Ignite Anatomic Shoulder System approved by the FDA?

Ignite Anatomic Shoulder System received FDA 510(k) clearance on 2021-05-20, under approval number K202716.

What company makes Ignite Anatomic Shoulder System?

Ignite Anatomic Shoulder System is manufactured by Ignite Orthopedics, LLC.

What is the FDA product code for Ignite Anatomic Shoulder System?

The FDA product code for Ignite Anatomic Shoulder System is MBF.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Ignite Orthopedics, LLC

K203108Ignite Stemless Anatomic Shoulder System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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