FDA product code · Orthopedic

Injector, Vertebroplasty (Does Not Contain Cement)

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

OARClass I21 CFR 888.4200510(k) exempt1 decision since 20053 recalls

FDA lists OAR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2005. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K051820, named by 1 later device.

Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

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 OAR 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 · OAR

FDA has decided no OAR device since 2007.

Median 510(k) review, days · OAR

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

Recalls per year · OAR

1in 2024

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OAR

12in 2025

2007high 22 (2017) · low 2 (2010)2025

MAUDE reports naming product code OAR, 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	4
2008	—	0	3
2009	—	0	3
2010	—	0	2
2011	—	0	6
2012	—	0	2
2013	—	1	6
2014	—	0	12
2015	—	0	8
2016	—	0	9
2017	—	1	22
2018	—	0	11
2019	—	0	14
2020	—	0	5
2021	—	0	13
2022	—	0	11
2023	—	0	14
2024	—	1	17
2025	—	0	12
2026	—	0	—

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

Planning a device in OAR? 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 888.4200.

KIH Dispenser, Cement

Injector, Vertebroplasty (Does Not Contain Cement)

Which predicates do OAR devices cite most?

What has FDA decided in OAR lately?

What has been recalled in OAR lately?

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