Cleared Traditional

K060988 - TOTAL AND HEMI SHOULDER SYSTEM

K060988 is an FDA 510(k) clearance for TOTAL AND HEMI SHOULDER SYSTEM, manufactured by Dvo Extremity Solutions, LLC. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K060988 · Dvo Extremity Solutions, LLC · Orthopedic device
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Dec 2006
Decision
240d
Days
Class 2
Risk

K060988 is an FDA 510(k) clearance for the TOTAL AND HEMI SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Dvo Extremity Solutions, LLC (Derby, US). The FDA issued a Cleared decision on December 6, 2006 after a review of 240 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 Dvo Extremity Solutions, LLC devices

FDA 510(k) Submission Details - K060988

510(k) Number K060988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date December 06, 2006
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 166
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K060988.
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
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029 · Zimmer GmbH · Oct 2006
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · DePuy Orthopaedics, Inc. · Jun 2006