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FDA 510(k)

Catalyst R1 Reverse Shoulder System

K-Number: K223655 · 2023-05-09

ApplicantCatalyst Orthoscience, Inc.
Decision Date2023-05-09
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyst R1 Reverse Shoulder System is a medical device manufactured by Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2023-05-09 under approval number K223655. 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 Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2023-05-09. It is manufactured by Catalyst Orthoscience, Inc.. The 510(k) number is K223655.

When was Catalyst R1 Reverse Shoulder System approved by the FDA?

Catalyst R1 Reverse Shoulder System received FDA 510(k) clearance on 2023-05-09, under approval number K223655.

What company makes Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is manufactured by Catalyst Orthoscience, Inc..

What is the FDA product code for Catalyst R1 Reverse Shoulder System?

The FDA product code for Catalyst R1 Reverse Shoulder System is PHX.

Related Clinical Trials

NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05357378 Safety and Effectiveness of the HIT Reverse HRS RECRUITING NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED

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 Catalyst Orthoscience, Inc.

K181287Catalyst CSR Shoulder System K173812Catalyst CSR 3 Peg Glenoids K191811Catalyst OrthoScience CSR Shoulder System K182500Catalyst CSR Press-Fit Humeral Components K211991Catalyst R1 Reverse Shoulder System K202611Catalyst OrthoScience R1 Reverse Shoulder System

View all 12 devices →

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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