FDA clears the first stemless reverse shoulder replacement for the US

Overview

Updated 1 hour ago

Reverse shoulder replacement has always meant a metal stem driven down the center of the upper arm bone. On November 5, 2026, the Food and Drug Administration cleared the first US system that skips the stem entirely.

FX Shoulder Solutions' Easytech Reversed grips bone at the outer rim of the humeral head instead of inside the canal. It took an eight-year US study, 90 patients and seven sites to get the clearance.

Why it matters

Patients with narrow, malformed or previously operated humeral canals may now get a reverse shoulder replacement without a stem in the bone.

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Key Indicators

Patients in the US study

Enrolled across seven sites between December 2018 and January 2022.

Investigational sites

Multicenter Investigational Device Exemption trial, registered as NCT 03806842.

Years from study start to clearance

Study opened in December 2018; FDA clearance came November 5, 2026.

92.3

Adjusted Constant score at 24 months

Up from 42.0 at baseline in the trial's two-year results.

Instrument trays

The system is designed to run on two trays instead of a full stemmed set.

Voices

Curated perspectives — historical figures and your fellow readers.

Organizations Involved

FX Shoulder Solutions, Inc.

Medical device manufacturer

Received FDA 510(k) clearance for Easytech Reversed on November 5, 2026

A shoulder-only implant maker based in Addison, Texas, that builds its product line around stemless fixation.

U.S. Food and Drug Administration

Federal regulator

Granted 510(k) clearance on November 5, 2026

The US agency that reviews medical devices for market clearance through the 510(k) pathway.

Timeline

2015 November 2026

7 events Latest: 4 days ago

Tap a bar to jump to that date

November 2026
FDA clears Easytech Reversed
Latest Clearance

The 510(k) clearance makes it the first stemless reverse shoulder system available in the US.
4 days ago
October 2024
Twenty-four-month results reported
Research

Adjusted Constant scores rose from 42.0 to 92.3; the study logged ten secondary surgeries, seven of them revisions.
October 2024
2023
Two-year follow-up completed
Clinical trial

Study follow-up ends, supplying the evidence package behind the 510(k) submission.
2023
January 2022
Enrollment closes at 90 patients
Clinical trial

Seven sites finish enrolling; FX calls it the first stemless reverse IDE to complete enrollment.
January 27th, 2022
2021
Anatomical version reaches the US market
Clearance

Easytech Stemless Anatomical brings the same humeral anchor base architecture to US surgeons.
2021
December 2018
US study opens under FDA approval
Clinical trial

FX starts a seven-site Investigational Device Exemption trial, registered as NCT 03806842.
December 2018
2015
Easytech Reversed enters clinical use in Europe
Milestone

The stemless reverse system begins use outside the US, building the international case history FX later cites.
2015

Scenarios

FX discloses first-year US case volume for Easytech Reversed

Possible Resolves by End of 2027

Discussed by: No published forecast; the company's launch messaging is the only public signal.

The clearance is a regulatory milestone, not proof of adoption. If FX announces a US case count or a surgeon training milestone within the first year, it signals the stemless approach is moving beyond a niche. If no number appears, the implant is likely still confined to a handful of high-volume shoulder centers.

A second stemless reverse system is cleared in the US

Possible Resolves by End of 2028

Discussed by: No named forecaster; the FDA's 510(k) database is the tracking record.

The 'first and only' claim has a shelf life. Competitors in shoulder arthroplasty have been moving toward shorter humeral fixation, and a rival 510(k) would end the exclusivity that FX is currently marketing. The trigger is any new clearance for a reverse shoulder system without a diaphyseal stem.

Published revision data undercut the stemless case

Unlikely Resolves by Q2 2029

Discussed by: The IDE investigators themselves flagged early migration and a revision rate they called similar to stemmed systems.

The trial reported two early implant migration or subsidence incidents and ten secondary surgeries in 90 patients. If independent registry or claims data later show stemless reverse revisions outpacing stemmed comparators, adoption narrows to the atypical-anatomy patients FX already names. If revision rates hold at parity, the addressable group widens.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2021

Easytech Stemless Anatomical reaches the US (2021)

FX brought a stemless anatomical shoulder implant to the US market, anchored to peripheral bone near the cortical rim rather than by a stem in the canal.

Then

US surgeons gained a stemless option in standard anatomical replacement.

Now

The anchor base became the platform FX reused for the reverse version, so part of the US clinical and commercial groundwork already existed.

Why this matters now

The reverse system inherits the anatomical implant's fixation architecture, which is why the clearance is an extension of an existing US product line rather than a new company entering the market.

2015