Cleared Special

K030037 - UNIVERSAL TOTAL WRIST SYSTEM (FDA 510(k) Clearance)

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

K030037 · Kinetikos Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
30d
Days
Class 2
Risk

K030037 is an FDA 510(k) clearance for the UNIVERSAL TOTAL WRIST SYSTEM. Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - 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 Kinetikos Medical, Inc. devices

Submission Details

510(k) Number K030037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date February 05, 2003
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
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.