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FDA 510(k)

Humeris® 135 Shoulder System

K-Number: K222936 · 2022-11-07

ApplicantFx Shoulder USA, Inc.
Decision Date2022-11-07
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeris® 135 Shoulder System is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2022-11-07 under approval number K222936. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Humeris® 135 Shoulder System?

Humeris® 135 Shoulder System is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K222936.

When was Humeris® 135 Shoulder System approved by the FDA?

Humeris® 135 Shoulder System received FDA 510(k) clearance on 2022-11-07, under approval number K222936.

What company makes Humeris® 135 Shoulder System?

Humeris® 135 Shoulder System is manufactured by Fx Shoulder USA, Inc..

What is the FDA product code for Humeris® 135 Shoulder System?

The FDA product code for Humeris® 135 Shoulder System is PHX.

Related Clinical Trials

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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 Fx Shoulder USA, Inc.

K19220632mm Glenosphere and Humeral Cup K191698TiN Coated Humeral Head K191146Humelock TiN Coated Glenosphere K193394Humeral Cup Stability & Humeral Cup 135/145o Stability K192799Glenoid Baseplate with Screw K210790Lateralized and Augmented Baseplates

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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