FDA product code · Orthopedic

Pin, Fixation, Smooth, Metallic

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

NDLClass II21 CFR 888.3040510(k) required2 decisions since 20011 recall

2 FDA decisions since 2001. 1 recall names this code; it is not Class I. The most-cited predicate is K010545, named by 4 later devices.

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 NDL 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 · NDL

FDA has decided no NDL device since 2007.

Median 510(k) review, days · NDL

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

Recalls per year · NDL

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDL

1in 2021

2007high 10 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	10
2010	—	0	1
2011	—	0	0
2012	—	0	1
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	1	0
2020	—	0	0
2021	—	0	1
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in NDL? 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 888.3040.

HWC Screw, Fixation, Bone QSR Sacroiliac Screw Placement Guide JEC Component, Traction, Invasive MBI Fastener, Fixation, Nondegradable, Soft Tissue MRY Appliances And Accessories, Fixation, Bone…PPQ Transtibial Anterior Cruciate Ligament Kit NJA Accessory, System, External Fixator…SCY Sacroiliac Joint Guidewire Placement Device HTY Pin, Fixation, Smooth NDJ Screw, Fixation, Bone, Non-Spinal, Metallic MJW Prosthesis, Subtalar, Plug, Polymer OVZ Pin, Fixation, Resorbable, Hard Tissue

Pin, Fixation, Smooth, Metallic

Which predicates do NDL devices cite most?

Which NDL devices have the deepest lineage?

What has FDA decided in NDL lately?

What has been recalled in NDL lately?

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