Cleared Special

Total Wrist Arthroplasty System (TWA)

K243381 · Skeletal Dynamics, Inc. · Orthopedic

Nov 2024

Decision

Days

Class 2

Risk

About This 510(k) Submission

K243381 is an FDA 510(k) clearance for the Total Wrist Arthroplasty System (TWA), a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on November 1, 2024, 2 days after receiving the submission on October 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K243381 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2024
Decision Date	November 01, 2024
Days to Decision	2 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWJ — Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3800