Cleared Special

K092873 - REVERSE SHOULDER PROSTHESIS

K092873 is an FDA 510(k) clearance for REVERSE SHOULDER PROSTHESIS, manufactured by Djo Surgical. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 39-day FDA review.

K092873 · Djo Surgical · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
39d
Days
Class 2
Risk

K092873 is an FDA 510(k) clearance for the REVERSE SHOULDER PROSTHESIS. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Djo Surgical (Austin, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 39 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092873

510(k) Number K092873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2009
Decision Date October 27, 2009
Days to Decision 39 days
Submission Type Special
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
83d faster than avg
Panel avg: 122d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 205
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K092873.
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · Exactech, Inc. · May 2010
AEQUALIS REVERSED SHOULDER PROSTHESIS
K100142 · Tornier · May 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · Exactech, Inc. · Jan 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · Exactech, Inc. · Oct 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · Smith & Nephew, Inc. · Sep 2008
AEQUALIS REVERSED SHOULDER PROSTHESIS
K081059 · Tornier · Jul 2008
K092873 · REVERSE SHOULDER PROSTHESIS
Download PDF FDA Summary Djo Surgical