Cleared Traditional

MODULAR HYBRID GLENOID (K060694) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060694 · Biomet Manufacturing Corp · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K060694.
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
K083435 · Arthrex, Inc. · Jun 2009
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620 · DePuy Orthopaedics, Inc. · Jun 2008
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032 · Arthrex, Inc. · Aug 2007
SOLAR REUNION FRACTURE STEM
K062113 · Howmedica Osteonics Corp. · Oct 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · DePuy Orthopaedics, Inc. · Jun 2006
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · DePuy Orthopaedics, Inc. · Oct 2005