Cleared Traditional

Total Wrist Arthroplasty System (TWA)

K233574 · Skeletal Dynamics · Orthopedic

Jul 2024

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K233574 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 (Miami, US). The FDA issued a Cleared decision on July 3, 2024, 239 days after receiving the submission on November 7, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K233574 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2023
Decision Date	July 03, 2024
Days to Decision	239 days
Submission Type	Traditional
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