Cleared Traditional

K130048 - REVERSE SHOULDER PROSTHESIS MONOBLOCK

K130048 is an FDA 510(k) clearance for REVERSE SHOULDER PROSTHESIS MONOBLOCK, manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 294-day FDA review.

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

FDA 510(k) Submission Details - K130048

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
Combination Product No
PCCP Authorized No
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.

KWS Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K130048.
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K133834 · Depuy(Ireland) · Apr 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · Exactech, Inc. · Feb 2014
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
K133462 · Aston Medical · Feb 2014
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · Materialise NV · Sep 2013
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013
SEVIIN FRACTURE SHOULDER
K131277 · Ingen Orthopedics, LLC · Aug 2013