Cleared Special

K080663 - PROFEMUR LX REVISION 5/8 COATED HIP STEM (FDA 510(k) Clearance)

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

K080663 · Wrightmedicaltechnologyinc · Orthopedic device
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Apr 2008
Decision
29d
Days
Class 3
Risk

K080663 is an FDA 510(k) clearance for the PROFEMUR LX REVISION 5/8 COATED HIP STEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 8, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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.

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Submission Details

510(k) Number K080663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date April 08, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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.