510(k) Report

FDA product code · Orthopedic

Prosthesis, Ligament, Ptfe

LWAClass IIIPMA required0 decisions since 19870 recalls

0 FDA decisions since 1987. 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 LWA 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 · LWA

FDA has decided no LWA device since 2007.

Median 510(k) review, days · LWA

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

Recalls per year · LWA

No recall names LWA since 2007.

Adverse event reports per year · LWA

1in 2024

2018: 12024: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code LWA, 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—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — LWA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LWA? 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