Cleared Traditional

K060694 - MODULAR HYBRID GLENOID

K060694 is an FDA 510(k) clearance for MODULAR HYBRID GLENOID, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K060694 · Biomet Manufacturing Corp · Orthopedic device
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Dec 2006
Decision
271d
Days
Class 2
Risk

K060694 is an FDA 510(k) clearance for the MODULAR HYBRID GLENOID. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 271 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 Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K060694

510(k) Number K060694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date December 11, 2006
Days to Decision 271 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
149d slower than avg
Panel avg: 122d · This submission: 271d
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 K060694.
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
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
K071090 · Zimmer Trabecular Metal Technology · Jun 2007
TOTAL AND HEMI SHOULDER SYSTEM
K060988 · Dvo Extremity Solutions, LLC · Dec 2006
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029 · Zimmer GmbH · Oct 2006
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006