Cleared Traditional

FX V135 Shoulder Prosthesis (K213117) - FDA 510(k) Clearance

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

K213117 · Fx Shoulder USA, Inc. · Orthopedic device
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Jun 2022
Decision
253d
Days
Class 2
Risk

K213117 is an FDA 510(k) clearance for the FX V135 Shoulder Prosthesis. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Fx Shoulder USA, Inc. (Dallas, US). The FDA issued a Cleared decision on June 7, 2022 after a review of 253 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 Fx Shoulder USA, Inc. devices

Submission Details

510(k) Number K213117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date June 07, 2022
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
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 K213117.
Tornier Perform Humeral System – Fracture
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INHANCETM Reverse Glenoid Peripheral Posts
K221467 · Depuy Ireland UC · Aug 2022
Catalyst R1 Reverse Shoulder System
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INHANCE™ Reverse Shoulder System
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PRIMA Humeral System and SMR Glenosphere Ø42
K212800 · Lima Corporate S.P.A. · Feb 2022
ARROW Short Stem Humeral System
K202024 · FH Industrie · Nov 2021