Cleared Traditional

K062029 - ANATOMICAL SHOULDER FRACTURE SYSTEM

K062029 is the FDA 510(k) clearance for ANATOMICAL SHOULDER FRACTURE SYSTEM by Zimmer GmbH. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K062029 · Zimmer GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
105d
Days
Class 2
Risk

K062029 is an FDA 510(k) clearance for the ANATOMICAL SHOULDER FRACTURE SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on October 31, 2006 after a review of 105 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 GmbH devices

Submission Details

510(k) Number K062029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date October 31, 2006
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 K062029.
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
K080402 · Encore Medical, L.P. · Mar 2008
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032 · Arthrex, Inc. · Aug 2007
MODULAR HYBRID GLENOID
K060694 · Biomet Manufacturing Corp · Dec 2006
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · DePuy Orthopaedics, Inc. · Jun 2006
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · Tornier · Mar 2006