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FDA 510(k)

JARVIS Glenoid Reverse Shoulder Prosthesis

K-Number: K252411 · 2025-08-28

ApplicantFH Industrie
Decision Date2025-08-28
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JARVIS Glenoid Reverse Shoulder Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252411. 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 JARVIS Glenoid Reverse Shoulder Prosthesis?

JARVIS Glenoid Reverse Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is FH Industrie. The 510(k) number is K252411.

When did JARVIS Glenoid Reverse Shoulder Prosthesis receive FDA 510(k) clearance?

JARVIS Glenoid Reverse Shoulder Prosthesis received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252411.

Who is the listed applicant for JARVIS Glenoid Reverse Shoulder Prosthesis?

The FDA 510(k) record lists FH Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JARVIS Glenoid Reverse Shoulder Prosthesis?

The FDA product code for JARVIS Glenoid Reverse Shoulder Prosthesis is PHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITINGNCT04629391Anatomic TSA vs RTSA for Glenohumeral ArthritisRECRUITINGNCT05002959TESS V3 Modular Total Shoulder System PMCFTERMINATEDNCT07678034Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis SystemRECRUITING

Other records listing FH Industrie as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254003JARVIS Metaphyseal StemK253345JARVIS Diaphyseal Stem StandardK242253JARVIS Glenoid Reverse Shoulder ProsthesisK232226ARROW Off-Centred Humeral InsertK220758e-Ortho Shoulder Software v1.1K202024ARROW Short Stem Humeral System

View all 9 devices →

Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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