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FDA 510(k)

Tornier Perform Humeral System – Stemless

K-Number: K220418 · 2022-09-14

ApplicantTornier, Inc.
Decision Date2022-09-14
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Perform Humeral System – Stemless is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2022-09-14 under approval number K220418. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Perform Humeral System – Stemless?

Tornier Perform Humeral System – Stemless is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Tornier, Inc.. The 510(k) number is K220418.

When was Tornier Perform Humeral System – Stemless approved by the FDA?

Tornier Perform Humeral System – Stemless received FDA 510(k) clearance on 2022-09-14, under approval number K220418.

What company makes Tornier Perform Humeral System – Stemless?

Tornier Perform Humeral System – Stemless is manufactured by Tornier, Inc..

What is the FDA product code for Tornier Perform Humeral System – Stemless?

The FDA product code for Tornier Perform Humeral System – Stemless is PKC.

Related Clinical Trials

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Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Tornier, Inc.

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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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