FDA product code · Orthopedic
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
1 FDA decision since 2016. 1 recall names this code; it is not Class I.
The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PNW 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 · PNW
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PNW
Too few PNW 510(k)s in any year since 2007 to give a median.
Recalls per year · PNW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNW
253in 2025
MAUDE reports naming product code PNW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | — | 0 | 1 |
| 2017 | 3 | — | 0 | 7 |
| 2018 | 3 | — | 0 | 13 |
| 2019 | 4 | — | 0 | 44 |
| 2020 | 1 | — | 0 | 36 |
| 2021 | 1 | — | 0 | 28 |
| 2022 | 0 | — | 0 | 94 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 1 | 41 |
| 2025 | 0 | — | 0 | 253 |
| 2026 | 0 | — | 0 | — |
Planning a device in PNW? 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