FDA product code · Orthopedic

Ligaments And Tendons, Synthetic

Name: FDA decisions, review times, recalls and adverse event reports for product code LML
Creator: 510(k) Report

LMLClass IIIPMA required2 decisions since 19870 recalls

2 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 LML 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 · LML

FDA has decided no LML device since 2007.

Median 510(k) review, days · LML

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

Recalls per year · LML

No recall names LML since 2007.

Adverse event reports per year · LML

No MAUDE report names LML since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — LML by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LML? 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

Ligaments And Tendons, Synthetic

What has FDA decided in LML lately?