Cleared Traditional

Freedom Wrist Arthroplasty System

K233674 · Ascension Orthopedics, Inc. · Orthopedic

May 2024

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K233674 is an FDA 510(k) clearance for the Freedom Wrist Arthroplasty System, a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 30, 2024, 196 days after receiving the submission on November 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K233674 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2023
Decision Date	May 30, 2024
Days to Decision	196 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