Cleared Traditional

K130895 - REUNION RSA SHOULDER SYSTEM

K130895 is the FDA 510(k) clearance for REUNION RSA SHOULDER SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K130895 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2013
Decision
270d
Days
Class 2
Risk

K130895 is an FDA 510(k) clearance for the REUNION RSA SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on December 27, 2013 after a review of 270 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K130895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2013
Decision Date December 27, 2013
Days to Decision 270 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
148d slower than avg
Panel avg: 122d · This submission: 270d
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 K130895.
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
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
K131353 · Biomet Manufacturing Corp · Oct 2013
COMPREHENSIVE REVERSE SHOULDER SCREWS
K132239 · Biomet Manufacturing Corp · Sep 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
K131575 · Exactech, Inc. · Jul 2013