Total Wrist Arthroplasty System (TWA)— 510(k) K233574

Name: FDA 510(k) clearance K233574
Creator: U.S. Food and Drug Administration
Published: 2024-07-03

Substantially Equivalent

Skeletal Dynamics

FDA 510(k) clearance K233574 for Total Wrist Arthroplasty System (TWA), Substantially Equivalent on 2024-07-03. Applicant: Skeletal Dynamics. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 2023-11-07
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWJ

view all

K243381 — Total Wrist Arthroplasty System (TWA)2024-11-01
K233674 — Freedom Wrist Arthroplasty System2024-05-30
K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System2020-10-15
K191525 — KinematX Total Wrist Arthroplasty System2020-03-04
K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM2014-03-24

Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.