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)
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.

View all Disc-O-Tech Medical Technologies, Ltd. devices

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 89
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
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · Howmedica Osteonics Corp. · Jan 2002
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309 · Plus Orthopedics · Mar 1999