Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JARVIS Metaphyseal Stem

K-Number: K254003 · 2026-01-09

ApplicantFH Industrie
Decision Date2026-01-09
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JARVIS Metaphyseal Stem is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K254003. 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 Metaphyseal Stem?

JARVIS Metaphyseal Stem is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is FH Industrie. The 510(k) number is K254003.

When did JARVIS Metaphyseal Stem receive FDA 510(k) clearance?

JARVIS Metaphyseal Stem received FDA 510(k) clearance on 2026-01-09, under 510(k) number K254003.

Who is the listed applicant for JARVIS Metaphyseal Stem?

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 Metaphyseal Stem?

The FDA product code for JARVIS Metaphyseal Stem is PHX.

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.

K253345JARVIS Diaphyseal Stem StandardK252411JARVIS Glenoid Reverse Shoulder ProsthesisK242253JARVIS 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.

↑