Cleared Traditional

Inset Reverse Total Shoulder System (K210533) - FDA 510(k) Clearance

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

K210533 · Shoulder Innovations, Inc. · Orthopedic device
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Aug 2021
Decision
177d
Days
Class 2
Risk

K210533 is an FDA 510(k) clearance for the Inset Reverse Total Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Shoulder Innovations, Inc. (Holland, US). The FDA issued a Cleared decision on August 20, 2021 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 Shoulder Innovations, Inc. devices

Submission Details

510(k) Number K210533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2021
Decision Date August 20, 2021
Days to Decision 177 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
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 K210533.
GLOBAL UNITE™ Platform Shoulder System
K212710 · Depuy Ireland UC · Sep 2021
Univers Revers Modular Glenoid System, Standard Augment Baseplates
K211074 · Arthrex, Inc. · Sep 2021
Lateralized and Augmented Baseplates
K210790 · Fx Shoulder USA, Inc. · Aug 2021
Tecomet Global Unite Short Stem Instrumentation
K211553 · Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. · Aug 2021
Catalyst R1 Reverse Shoulder System
K211991 · Catalyst Orthoscience, Inc. · Jul 2021
DELTA XTEND Reverse Shoulder System
K203694 · Depuy Ireland UC · Jul 2021