Cleared Traditional

REVERSE SHOULDER PROSTHESIS MONOBLOCK (K130048) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130048 · Encore Medical, L.P. · Orthopedic device
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Oct 2013
Decision
294d
Days
Class 2
Risk

K130048 is an FDA 510(k) clearance for the REVERSE SHOULDER PROSTHESIS MONOBLOCK. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on October 29, 2013 after a review of 294 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K130048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2013
Decision Date October 29, 2013
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K130048.
Arthrex VaultLock Glenoid
K161108 · Arthrex, Inc. · Aug 2016
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · Arthrex, Inc. · May 2013
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · Exactech, Inc. · Nov 2012