FDA product code · Orthopedic

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

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

QADClass II21 CFR 888.3023510(k) required7 decisions since 20170 recalls

7 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 98 days (half between 98 and 98). No recall names this code. The most-cited predicate is K181228, named by 1 later device.

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a…

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 QAD 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 · QAD

1in 2024

2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAD

30in 2020

2007high 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QAD

No recall names QAD since 2007.

Adverse event reports per year · QAD

21in 2025

2007high 47 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	2	—	4
2019	0	—	8
2020	3	30	7
2021	0	—	8
2022	0	—	25
2023	0	—	47
2024	1	—	34
2025	0	—	21
2026	0	—	—

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

Planning a device in QAD? 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

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Which predicates do QAD devices cite most?

Which QAD devices have the deepest lineage?

What has FDA decided in QAD lately?