Cleared Special

K030972 - FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

K030972 is an FDA 510(k) clearance for FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM..., manufactured by Disc-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Special 510(k) pathway after a 63-day FDA review.

K030972 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
63d
Days
Class 2
Risk

K030972 is an FDA 510(k) clearance for the FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH). Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Herzelia, IL). The FDA issued a Cleared decision on May 30, 2003 after a review of 63 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.

FDA 510(k) Submission Details - K030972

510(k) Number K030972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date May 30, 2003
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

KWL Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K030972.
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
CONSENSUS UNIPOLAR HEAD, COCR
K030205 · Hayes Medical, Inc. · Apr 2003
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · Howmedica Osteonics Corp. · Jan 2002
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
K030972 · FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
Download PDF FDA Summary Disc-O-Tech Medical T…