FDA product code · Orthopedic

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

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

OBTClass II21 CFR 888.3030510(k) required6 decisions since 20100 recalls

6 FDA decisions since 2010. 510(k) reviews decided 2021–2025 took a median of 273 days (half between 273 and 273). No recall names this code. The most-cited predicate is K093442, named by 3 later devices.

Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or…

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 OBT 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 · OBT

1in 2022

2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBT

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

Recalls per year · OBT

No recall names OBT since 2007.

Adverse event reports per year · OBT

2in 2025

2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code OBT, 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	1	—	0
2011	1	—	1
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	1
2016	0	—	0
2017	0	—	0
2018	2	—	0
2019	1	—	0
2020	0	—	3
2021	0	—	1
2022	1	—	1
2023	0	—	1
2024	0	—	0
2025	0	—	2
2026	0	—	—

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

Planning a device in OBT? 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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Other codes under 21 CFR 888.3030.

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Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Which predicates do OBT devices cite most?

Which OBT devices have the deepest lineage?

What has FDA decided in OBT lately?

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