510(k) Report

FDA product code · Orthopedic

Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

JWIClass II21 CFR 888.3800510(k) required3 decisions since 19800 recalls

3 FDA decisions since 1980. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of JWI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · JWI

FDA has decided no JWI device since 2007.

Median 510(k) review, days · JWI

Too few JWI 510(k)s in any year since 2007 to give a median.

Recalls per year · JWI

No recall names JWI since 2007.

Adverse event reports per year · JWI

4in 2024

2018: 12019: 22022: 12023: 22024: 4
2007high 4 (2024) · low 0 (2007)2025

MAUDE reports naming product code JWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—02
20200—00
20210—00
20220—01
20230—02
20240—04
20250—00
20260—0—
FIG. 1 — JWI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JWI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 888.3800.