Cleared Traditional

K092331 - DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200 (FDA 510(k) Clearance)

Also includes:
428-00-050/110

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

K092331 · Encore Medical, L.P. · Orthopedic device
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Mar 2010
Decision
211d
Days
Class 3
Risk

K092331 is an FDA 510(k) clearance for the DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on March 3, 2010 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K092331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date March 03, 2010
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
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.