Cleared Traditional

Full Wedge Lateralized and Augmented Baseplates (K240278) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240278 · Fx Shoulder USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
104d
Days
Class 2
Risk

K240278 is an FDA 510(k) clearance for the Full Wedge Lateralized and Augmented Baseplates. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Fx Shoulder USA, Inc. (Addison, US). The FDA issued a Cleared decision on May 15, 2024 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Fx Shoulder USA, Inc. devices

Submission Details

510(k) Number K240278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date May 15, 2024
Days to Decision 104 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K240278.
Blueprint Patient-Specific Instrumentation
K241491 · Stryker Corporation (Tornier, S.A.S.) · Oct 2024
Equinoxe® Central Screw Baseplate System
K233482 · Exactech, Inc. · Jul 2024
AltiVate Reverse® Glenoid
K233481 · Encore Medical, L.P. · May 2024
Augment Off-Axis Instrument System
K241043 · Fix Surgical · May 2024
Catalyst F1x Shoulder System
K234105 · Catalyst Orthoscience, Inc. · Apr 2024
Augment Off-Axis Instrument System
K233148 · Fix Surgical · Mar 2024