Arthrosurface WristMotion Total Wrist Arthroplasty System— 510(k) K200718

Name: FDA 510(k) clearance K200718
Creator: U.S. Food and Drug Administration
Published: 2020-10-15

Substantially Equivalent

Arthrosurface, Inc.

FDA 510(k) clearance K200718 for Arthrosurface WristMotion Total Wrist Arthroplasty System, Substantially Equivalent on 2020-10-15. Applicant: Arthrosurface, Inc.. Device class: 2.

Clearance details

Applicant: Arthrosurface, Inc.
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 2020-03-19
Decision date: 2020-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWJ

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K243381 — Total Wrist Arthroplasty System (TWA)2024-11-01
K233574 — Total Wrist Arthroplasty System (TWA)2024-07-03
K233674 — Freedom Wrist Arthroplasty System2024-05-30
K191525 — KinematX Total Wrist Arthroplasty System2020-03-04
K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM2014-03-24

More clearances from Arthrosurface, Inc.

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K203375 — OVOMotion Reverse Shoulder Arthroplasty System2021-06-24
K190261 — BOSS Toe Fixation System2019-08-14
K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System2018-06-14
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18
K172383 — Arthrosurface Bone Screws2017-12-22

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.