Cleared Special

K141006 - RSP HUMERAL SOCKET INSERT

K141006 is an FDA 510(k) clearance for RSP HUMERAL SOCKET INSERT, manufactured by Djo Global. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 48-day FDA review.

K141006 · Djo Global · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
48d
Days
Class 2
Risk

K141006 is an FDA 510(k) clearance for the RSP HUMERAL SOCKET INSERT. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Djo Global (Austin, US). The FDA issued a Cleared decision on June 5, 2014 after a review of 48 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 - K141006

510(k) Number K141006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date June 05, 2014
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 K141006.
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
K140082 · Tornier S.A.S. · Jul 2014
POROUS COATED COMPREHENSIVE FRACTURE STEMS
K140652 · Biomet Manufacturing Corp · Jul 2014
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
K141029 · Tornier, Inc. · Jun 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · Zimmer, Inc. · May 2014
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
K140904 · Encore Medical, L.P. · May 2014
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
K130550 · Encore Medical, L.P. · Mar 2014
K141006 · RSP HUMERAL SOCKET INSERT
Download PDF FDA Summary Djo Global