FDA product code · Orthopedic
Internal Hinged Elbow Fixator
3 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 203 days (half between 198 and 207). No recall names this code. The most-cited predicate is K153208, named by 2 later devices.
The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OZI 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 · OZI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OZI
Too few OZI 510(k)s in any year since 2007 to give a median.
Recalls per year · OZI
No recall names OZI since 2007.
Adverse event reports per year · OZI
3in 2025
MAUDE reports naming product code OZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
Planning a device in OZI? 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) ReportRelated product codes
Other codes under 21 CFR 888.3030.