FDA product code · Orthopedic
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
13 FDA decisions since 1982. 17 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MRA 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 · MRA
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRA
Too few MRA 510(k)s in any year since 2007 to give a median.
Recalls per year · MRA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRA
88in 2025
MAUDE reports naming product code MRA, 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 | 10 | — | 0 | 117 |
| 2008 | 12 | — | 5 | 146 |
| 2009 | 14 | — | 1 | 91 |
| 2010 | 14 | — | 0 | 188 |
| 2011 | 12 | — | 6 | 248 |
| 2012 | 28 | — | 2 | 283 |
| 2013 | 17 | — | 1 | 235 |
| 2014 | 9 | — | 0 | 281 |
| 2015 | 18 | — | 0 | 330 |
| 2016 | 26 | — | 0 | 367 |
| 2017 | 16 | — | 0 | 540 |
| 2018 | 11 | — | 0 | 696 |
| 2019 | 17 | — | 0 | 641 |
| 2020 | 13 | — | 0 | 371 |
| 2021 | 18 | — | 0 | 109 |
| 2022 | 33 | — | 0 | 89 |
| 2023 | 19 | — | 0 | 132 |
| 2024 | 16 | — | 0 | 118 |
| 2025 | 18 | — | 0 | 88 |
| 2026 | 7 | — | 0 | — |
Planning a device in MRA? 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