FDA product code · Orthopedic

Cerclage, Fixation, Metallic

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

NDDClass II21 CFR 888.3010510(k) required1 decision since 20010 recalls

1 FDA decision since 2001. 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 NDD 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 · NDD

FDA has decided no NDD device since 2007.

Median 510(k) review, days · NDD

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

Recalls per year · NDD

No recall names NDD since 2007.

Adverse event reports per year · NDD

No MAUDE report names NDD 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 — NDD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NDD? 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

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Cerclage, Fixation, Metallic

What has FDA decided in NDD lately?

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