FDA product code · Orthopedic
Orthopedic Manual Surgical Instrument
FDA lists LXH 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. 58 FDA decisions since 1980. 378 recalls name this code, 0 of them Class I. The most-cited predicate is K792670, named by 3 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LXH 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 · LXH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXH
Too few LXH 510(k)s in any year since 2007 to give a median.
Recalls per year · LXH
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXH
6,119in 2025
MAUDE reports naming product code LXH, 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 | — | 41 | 398 |
| 2008 | 0 | — | 41 | 833 |
| 2009 | 0 | — | 25 | 1,569 |
| 2010 | 1 | — | 54 | 2,329 |
| 2011 | 0 | — | 12 | 2,488 |
| 2012 | 0 | — | 29 | 2,059 |
| 2013 | 0 | — | 17 | 4,149 |
| 2014 | 1 | — | 12 | 3,844 |
| 2015 | 0 | — | 7 | 5,944 |
| 2016 | 0 | — | 9 | 6,365 |
| 2017 | 0 | — | 14 | 4,133 |
| 2018 | 0 | — | 23 | 4,685 |
| 2019 | 1 | — | 10 | 5,224 |
| 2020 | 0 | — | 3 | 4,766 |
| 2021 | 0 | — | 2 | 4,832 |
| 2022 | 0 | — | 4 | 4,844 |
| 2023 | 0 | — | 4 | 5,163 |
| 2024 | 0 | — | 3 | 6,319 |
| 2025 | 0 | — | 0 | 6,119 |
| 2026 | 0 | — | 8 | — |
Planning a device in LXH? 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 888.4540.