FDA product code · Orthopedic
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
8 FDA decisions since 1989. 510(k) reviews decided 2021–2025 took a median of 62 days (half between 62 and 62). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K896580, named by 8 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 LZY 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 · LZY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZY
Too few LZY 510(k)s in any year since 2007 to give a median.
Recalls per year · LZY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZY
74in 2025
MAUDE reports naming product code LZY, 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 | 9 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 38 |
| 2011 | 1 | — | 0 | 43 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 97 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 72 |
| 2018 | 0 | — | 0 | 67 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 1 | 74 |
| 2026 | 0 | — | 0 | — |
Planning a device in LZY? 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 888.3360.