Cleared Traditional

K014072 - FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014072 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Mar 2002
Decision
88d
Days
Class 2
Risk

K014072 is an FDA 510(k) clearance for the FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH). Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Washington, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K014072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date March 08, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 98
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