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FDA 510(k)

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System

K-Number: K214001 · 2023-03-15

ApplicantBiomet Manufacturing Corp
Decision Date2023-03-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2023-03-15 under approval number K214001. 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 Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K214001.

When was Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System approved by the FDA?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System received FDA 510(k) clearance on 2023-03-15, under approval number K214001.

What company makes Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is manufactured by Biomet Manufacturing Corp.

What is the FDA product code for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

The FDA product code for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is PHX.

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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) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Biomet Manufacturing Corp

K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) K153558Ventix Suture Anchor K152262Ventix Knotless Anchors K152868ExpressBraid Graft Manipulation K153398Comprehensive SRS/Nexel Elbow K163651ExpressBraid Graft Manipulation

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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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