Cleared Special

ARTELON CMC SPACER ARTHRO (K061954) - FDA 510(k) Clearance

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

K061954 · Artimplant AB · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
325d
Days
Class 2
Risk

K061954 is an FDA 510(k) clearance for the ARTELON CMC SPACER ARTHRO. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Artimplant AB (Washington, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - 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. Elevated predicate reliance 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 Artimplant AB devices

Submission Details

510(k) Number K061954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2006
Decision Date June 01, 2007
Days to Decision 325 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
203d slower than avg
Panel avg: 122d · This submission: 325d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
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 - KYI Prosthesis, Wrist, Carpal Trapezium

Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K061954.
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K201072 · Ensemble Orthopedics, LLC · Dec 2020
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K951471 · Wrightmedicaltechnologyinc · Aug 1995