Cleared Traditional

K062029 - ANATOMICAL SHOULDER FRACTURE SYSTEM

K062029 is an FDA 510(k) clearance for ANATOMICAL SHOULDER FRACTURE SYSTEM, manufactured by Zimmer GmbH. The device is a Class 2 Orthopedic device with 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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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

FDA 510(k) Submission Details - K062029

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.

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 K062029.
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
K071090 · Zimmer Trabecular Metal Technology · Jun 2007
MODULAR HYBRID GLENOID
K060694 · Biomet Manufacturing Corp · Dec 2006
TOTAL AND HEMI SHOULDER SYSTEM
K060988 · Dvo Extremity Solutions, LLC · 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