Cleared Traditional

K142403 - Anatomical Shoulder System/Anatomical S...

K142403 is the FDA 510(k) clearance for Anatomical Shoulder System/Anatomical S... by Zimmer GmbH. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K142403 · Zimmer GmbH · Orthopedic device
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Nov 2014
Decision
89d
Days
Class 2
Risk

K142403 is an FDA 510(k) clearance for the Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Sho.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on November 24, 2014 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer GmbH devices

Submission Details

510(k) Number K142403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date November 24, 2014
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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
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