Cleared Traditional

K040070 - ARTELON SPACER CMC-1

K040070 is an FDA 510(k) clearance for ARTELON SPACER CMC-1, 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 251-day FDA review.

K040070 · Artimplant AB · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
251d
Days
Class 2
Risk

K040070 is an FDA 510(k) clearance for the ARTELON SPACER CMC-1. 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 September 21, 2004 after a review of 251 days - an extended review cycle.

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. Standard predicate reliance. 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 - K040070

510(k) Number K040070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2004
Decision Date September 21, 2004
Days to Decision 251 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
129d slower than avg
Panel avg: 122d · This submission: 251d
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 K040070.
NEXA CARPO METACARPAL IMPLANT
K060386 · Nexa Orthopedics, Inc. · May 2006
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
K052596 · Biopro, Inc. · Nov 2005
ASCENSION PYROSPHERE (PCS)
K042690 · Ascension Orthopedics, Inc. · Nov 2004
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
K041451 · Ascension Orthopedics, Inc. · Aug 2004
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · Avanta Orthopaedics, Inc. · Jun 1997