FDA product code · Orthopedic
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
3 FDA decisions since 2006. No recall names this code.
Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NXT 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 · NXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXT
Too few NXT 510(k)s in any year since 2007 to give a median.
Recalls per year · NXT
No recall names NXT since 2007.
Adverse event reports per year · NXT
91in 2025
MAUDE reports naming product code NXT, 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 | 6 | — | 0 | 14 |
| 2008 | 6 | — | 0 | 9 |
| 2009 | 9 | — | 0 | 137 |
| 2010 | 4 | — | 0 | 259 |
| 2011 | 7 | — | 0 | 422 |
| 2012 | 1 | — | 0 | 502 |
| 2013 | 1 | — | 0 | 699 |
| 2014 | 5 | — | 0 | 700 |
| 2015 | 2 | — | 0 | 363 |
| 2016 | 3 | — | 0 | 358 |
| 2017 | 1 | — | 0 | 460 |
| 2018 | 2 | — | 0 | 579 |
| 2019 | 0 | — | 0 | 468 |
| 2020 | 1 | — | 0 | 534 |
| 2021 | 0 | — | 0 | 528 |
| 2022 | 1 | — | 0 | 425 |
| 2023 | 1 | — | 0 | 143 |
| 2024 | 1 | — | 0 | 159 |
| 2025 | 1 | — | 0 | 91 |
| 2026 | 0 | — | 0 | — |
Planning a device in NXT? 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