Cleared Traditional

K101996 - DEPUY GLOBAL UNITE SHOULDER SYSTEM

K101996 is an FDA 510(k) clearance for DEPUY GLOBAL UNITE SHOULDER SYSTEM, manufactured by Depuy(Ireland). The device is a Class 2 Orthopedic device with product code PHX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K101996 · Depuy(Ireland) · Orthopedic device
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Dec 2010
Decision
153d
Days
Class 2
Risk

K101996 is an FDA 510(k) clearance for the DEPUY GLOBAL UNITE SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on December 15, 2010 after a review of 153 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 Depuy(Ireland) devices

FDA 510(k) Submission Details - K101996

510(k) Number K101996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2010
Decision Date December 15, 2010
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 184
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K101996.
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · Tornier, Inc. · Jun 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
K110708 · Exactech, Inc. · Apr 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · Encore Medical, L.P. · Jan 2011
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
K102951 · Exactech, Inc. · Nov 2010
BIO-MODULAR REVERSE SHOLDER
K093803 · Biomet Manufacturing Corp · Oct 2010
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012
K100741 · Encore Medical, L.P. · Aug 2010