Cleared Traditional

Augment Off-Axis Instrument System (K233148) - FDA 510(k) Clearance

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

K233148 · Fix Surgical · Orthopedic device
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Mar 2024
Decision
177d
Days
Class 2
Risk

K233148 is an FDA 510(k) clearance for the Augment Off-Axis Instrument System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Fix Surgical (Conshohocken, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 177 days - an extended review cycle.

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 Fix Surgical devices

Submission Details

510(k) Number K233148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date March 22, 2024
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 122d · This submission: 177d
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 K233148.
Full Wedge Lateralized and Augmented Baseplates
K240278 · Fx Shoulder USA, Inc. · May 2024
Augment Off-Axis Instrument System
K241043 · Fix Surgical · May 2024
Catalyst F1x Shoulder System
K234105 · Catalyst Orthoscience, Inc. · Apr 2024
BLUEPRINT™ Patient Specific Instrumentation
K232265 · Tornier S.A.S. · Feb 2024
LINK Embrace Shoulder System - Reverse Configuration
K231445 · Waldemar Link GmbH & Co. KG · Nov 2023
Glenoid Reconstruction System – Full Wedge Baseplate
K231911 · Medacta International S.A. · Nov 2023