Cleared Traditional

K131129 - CAS PSI SHOULDER

K131129 is the FDA 510(k) clearance for CAS PSI SHOULDER by Zimmer Cas. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K131129 · Zimmer Cas · Orthopedic device
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Aug 2013
Decision
120d
Days
Class 2
Risk

K131129 is an FDA 510(k) clearance for the CAS PSI SHOULDER. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer Cas (Warsaw, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 120 days - within the typical 510(k) review window.

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 Zimmer Cas devices

Submission Details

510(k) Number K131129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date August 20, 2013
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K131129.
REVERSE SHOULDER PROSTHESIS MONOBLOCK
K130048 · Encore Medical, L.P. · Oct 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · Materialise NV · Sep 2013
ARTHREX UNIVERS APEX
K131633 · Arthrex, Inc. · Sep 2013
SMR 3-PEGS GLENOIDS
K130642 · Lima Corporate S.P.A. · Jun 2013
LIMACORPORATE SMR CTA HUMERAL HEADS
K131112 · Lima Corporate S.P.A. · Jun 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · Arthrex, Inc. · May 2013