Cleared Special

K061954 - ARTELON CMC SPACER ARTHRO

K061954 is an FDA 510(k) clearance for ARTELON CMC SPACER ARTHRO, manufactured by Artimplant AB. The device is a Class 2 Orthopedic device with product code KYI cleared through the Special 510(k) pathway after a 325-day FDA review.

K061954 · Artimplant AB · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K061954

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 122d · This submission: 325d
Pathway characteristics
Modification to existing cleared device.

KYI Device Classification - Class 2, Special Controls

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

All 23
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K061954.
ASCENSION NUGRIP CMC IMPLANT
K112278 · Ascension Orthopedic · Nov 2011
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
K092548 · Extremity Medical, LLC · Dec 2009
ARTELON STT SPACER
K061956 · Artimplant AB · Jun 2007
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K061451 · Ascension Orthopedics, Inc. · Aug 2006
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
K061089 · Biopro, Inc. · Jun 2006
NEXA CARPO METACARPAL IMPLANT
K060386 · Nexa Orthopedics, Inc. · May 2006
K061954 · ARTELON CMC SPACER ARTHRO
Download PDF FDA Summary Artimplant AB