Cleared Special

JARVIS Metaphyseal Stem (K254003) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K254003 · FH Industrie · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
25d
Days
Class 2
Risk

K254003 is an FDA 510(k) clearance for the JARVIS Metaphyseal Stem. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by FH Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on January 9, 2026 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all FH Industrie devices

Submission Details

510(k) Number K254003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date January 09, 2026
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

MRC Global, LLC
Jen McBride

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K254003.
SMR Shoulder System
K252352 · Lima Corporate S.P.A. · Jan 2026
N22 EZ Glenosphere
K252516 · Shoulder Innovations, Inc. · Jan 2026
AltiVate Reverse® ADLC Glenosphere
K252567 · Encore Medical, L.P. · Jan 2026
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
K252788 · Tornier, Inc. · Jan 2026
MSS - Humeral reverse liners extension
K250338 · Medacta International S.A. · Oct 2025
JARVIS Diaphyseal Stem Standard
K253345 · FH Industrie · Oct 2025