510(k) Report

FDA product code · Orthopedic

Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

LMNClass IIIPMA required1 decision since 19830 recalls

1 FDA decision since 1983. 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 LMN 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 · LMN

FDA has decided no LMN device since 2007.

Median 510(k) review, days · LMN

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

Recalls per year · LMN

No recall names LMN since 2007.

Adverse event reports per year · LMN

1in 2022

2008: 42009: 352013: 12022: 1
2007high 35 (2009) · low 0 (2007)2025

MAUDE reports naming product code LMN, 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—04
20090—035
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LMN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LMN? 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