Cleared Traditional

K173073 - AltiVate Anatomic to Reverse Conversion...

K173073 is the FDA 510(k) clearance for AltiVate Anatomic to Reverse Conversion... by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K173073 · Encore Medical, L.P. · Orthopedic device
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Dec 2017
Decision
88d
Days
Class 2
Risk

K173073 is an FDA 510(k) clearance for the AltiVate Anatomic to Reverse Conversion Module. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on December 26, 2017 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K173073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 26, 2017
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K173073.
ARROW Reverse Porous Glenoid
K171789 · Fournitures Hospitalieres Industrie · Jan 2018
GLOBAL UNITE Platform Shoulder System
K170748 · Depuy Ireland UC · Jan 2018
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
K172502 · Biomet Manufacturing Corp · Jan 2018
Arthrex Univers Revers Apex Humeral Stems
K170414 · Arthrex, Inc. · Dec 2017
Medacta Shoulder System: Threaded Glenoid Baseplate
K171058 · Medacta International S.A. · Dec 2017
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
K172767 · Zimmer, Inc. · Nov 2017