Cleared Special

NEXFLEX TOTAL HIP SYSTEM (K033580) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033580 · Nexmed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
266d
Days
Class 2
Risk

K033580 is an FDA 510(k) clearance for the NEXFLEX TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Nexmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 5, 2004 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nexmed, Inc. devices

Submission Details

510(k) Number K033580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date August 05, 2004
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K033580.
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · Zimmer, Inc. · Nov 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
K042776 · Zimmer, Inc. · Nov 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · Exactech, Inc. · Sep 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109 · Zimmer, Inc. · Jul 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
K040544 · Depuy, Inc. · May 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · DePuy Orthopaedics, Inc. · May 2004