Cleared Traditional

K061956 - ARTELON STT SPACER

K061956 is an FDA 510(k) clearance for ARTELON STT SPACER, manufactured by Artimplant AB. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K061956 · Artimplant AB · Orthopedic device
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Jun 2007
Decision
331d
Days
Class 2
Risk

K061956 is an FDA 510(k) clearance for the ARTELON STT SPACER. 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 7, 2007 after a review of 331 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Artimplant AB devices

FDA 510(k) Submission Details - K061956

510(k) Number K061956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2006
Decision Date June 07, 2007
Days to Decision 331 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
209d slower than avg
Panel avg: 122d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 20
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K061956.
Stablyx CMC Arthroplasty Implant System
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STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
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EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
K092548 · Extremity Medical, LLC · Dec 2009
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