Cleared Special

K014226 - UNITRAX MODULAR UNIPOLAR SYSTEM

K014226 is the FDA 510(k) clearance for UNITRAX MODULAR UNIPOLAR SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K014226 · Howmedica Osteonics Corp. · Orthopedic device
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Jan 2002
Decision
30d
Days
Class 2
Risk

K014226 is an FDA 510(k) clearance for the UNITRAX MODULAR UNIPOLAR SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on January 25, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K014226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date January 25, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 75
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K014226.
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006
SOLITUDE UNIPOLAR HEAD
K042973 · Ortho Development Corp. · Jan 2005
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · Exactech, Inc. · Jan 2004
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309 · Plus Orthopedics · Mar 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999