Cleared Special

K180744 - Stablyx CMC Arthroplasty Implant System

K180744 is the FDA 510(k) clearance for Stablyx CMC Arthroplasty Implant System by Skeletal Dynamics, LLC. It is a Class 2 Orthopedic device (product code KYI) cleared through the Special 510(k) pathway after a 20-day FDA review.

K180744 · Skeletal Dynamics, LLC · Orthopedic device
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Apr 2018
Decision
20d
Days
Class 2
Risk

K180744 is an FDA 510(k) clearance for the Stablyx CMC Arthroplasty Implant System. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on April 11, 2018 after a review of 20 days - a notably fast clearance cycle.

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. Low regulatory complexity 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 Skeletal Dynamics, LLC devices

Submission Details

510(k) Number K180744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date April 11, 2018
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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

All 9
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K180744.
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K201072 · Ensemble Orthopedics, LLC · Dec 2020
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
K061089 · Biopro, Inc. · Jun 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
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · Wrightmedicaltechnologyinc · Feb 1997