FDA product code · Orthopedic
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
2 FDA decisions since 1985. 257 recalls name this code, 0 of them Class I. The most-cited predicate is P830055, named by 1 later device.
This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NJL 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 · NJL
23in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NJL
Too few NJL 510(k)s in any year since 2007 to give a median.
Recalls per year · NJL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJL
1,088in 2025
MAUDE reports naming product code NJL, 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 | 4 | — | 49 | 369 |
| 2008 | 6 | — | 1 | 690 |
| 2009 | 12 | — | 4 | 808 |
| 2010 | 4 | — | 0 | 1,008 |
| 2011 | 8 | — | 0 | 1,102 |
| 2012 | 11 | — | 0 | 1,309 |
| 2013 | 15 | — | 1 | 1,298 |
| 2014 | 21 | — | 0 | 1,301 |
| 2015 | 23 | — | 0 | 1,068 |
| 2016 | 17 | — | 3 | 1,387 |
| 2017 | 21 | — | 9 | 1,142 |
| 2018 | 27 | — | 0 | 1,265 |
| 2019 | 30 | — | 1 | 1,968 |
| 2020 | 28 | — | 0 | 1,864 |
| 2021 | 18 | — | 0 | 2,644 |
| 2022 | 30 | — | 0 | 2,319 |
| 2023 | 17 | — | 0 | 1,593 |
| 2024 | 23 | — | 0 | 1,236 |
| 2025 | 23 | — | 0 | 1,088 |
| 2026 | 28 | — | 0 | — |
Planning a device in NJL? 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