Cleared Traditional

K092548 - EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS

K092548 is an FDA 510(k) clearance for EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K092548 · Extremity Medical, LLC · Orthopedic device
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Dec 2009
Decision
118d
Days
Class 2
Risk

K092548 is an FDA 510(k) clearance for the EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 118 days - within the typical 510(k) review window.

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 Extremity Medical, LLC devices

FDA 510(k) Submission Details - K092548

510(k) Number K092548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date December 15, 2009
Days to Decision 118 days
Submission Type Traditional
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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 22
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K092548.
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ASCENSION NUGRIP CMC IMPLANT
K112278 · Ascension Orthopedic · Nov 2011
ARTELON STT SPACER
K061956 · Artimplant AB · Jun 2007
ARTELON CMC SPACER ARTHRO
K061954 · Artimplant AB · Jun 2007
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K061451 · Ascension Orthopedics, Inc. · Aug 2006