Total Wrist Arthroplasty System (TWA)— 510(k) K243381

Name: FDA 510(k) clearance K243381
Creator: U.S. Food and Drug Administration
Published: 2024-11-01

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K243381 for Total Wrist Arthroplasty System (TWA), Substantially Equivalent on 2024-11-01. Applicant: Skeletal Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, Inc.
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 2024-10-30
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWJ

view all

K233574 — Total Wrist Arthroplasty System (TWA)2024-07-03
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

More clearances from Skeletal Dynamics, Inc.

view all

K261770 — Suture Button Repair System2026-07-29
K254288 — Clavicle Fixation System2026-03-23
K252949 — Geminus Volar Distal Radius Plating System2025-11-13
K242436 — Proximal Humerus Fixation System2024-11-14
K241815 — Protean Fragment Plating System2024-09-26

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.