Cleared Traditional

K073499 - VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K073499 · Zimmer, Inc. · Orthopedic device
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Aug 2008
Decision
238d
Days
Class 3
Risk

K073499 is an FDA 510(k) clearance for the VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 238 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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, Inc. devices

Submission Details

510(k) Number K073499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2007
Decision Date August 07, 2008
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.