FDA product code · Orthopedic
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
2 FDA decisions since 1992. 14 recalls name this code, 0 of them Class I.
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NRA 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 · NRA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRA
Too few NRA 510(k)s in any year since 2007 to give a median.
Recalls per year · NRA
13in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRA
440in 2025
MAUDE reports naming product code NRA, 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 | 5 | — | 0 | 2 |
| 2008 | 6 | — | 1 | 11 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 3 | — | 0 | 51 |
| 2011 | 6 | — | 13 | 143 |
| 2012 | 5 | — | 0 | 109 |
| 2013 | 8 | — | 0 | 158 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 4 | — | 0 | 590 |
| 2016 | 6 | — | 0 | 532 |
| 2017 | 8 | — | 0 | 676 |
| 2018 | 14 | — | 0 | 251 |
| 2019 | 12 | — | 0 | 518 |
| 2020 | 2 | — | 0 | 189 |
| 2021 | 1 | — | 0 | 234 |
| 2022 | 3 | — | 0 | 281 |
| 2023 | 1 | — | 0 | 274 |
| 2024 | 4 | — | 0 | 263 |
| 2025 | 3 | — | 0 | 440 |
| 2026 | 8 | — | 0 | — |
Planning a device in NRA? 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