FDA product code · Orthopedic
Prosthesis, Ankle, Uncemented, Non-Constrained
2 FDA decisions since 2009. 4 recalls name this code, 0 of them Class I.
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NTG 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 · NTG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NTG
Too few NTG 510(k)s in any year since 2007 to give a median.
Recalls per year · NTG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NTG
14in 2025
MAUDE reports naming product code NTG, 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 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 92 |
| 2015 | 0 | — | 0 | 341 |
| 2016 | 2 | — | 0 | 86 |
| 2017 | 0 | — | 0 | 82 |
| 2018 | 1 | — | 2 | 93 |
| 2019 | 3 | — | 0 | 129 |
| 2020 | 2 | — | 0 | 545 |
| 2021 | 7 | — | 0 | 89 |
| 2022 | 4 | — | 0 | 50 |
| 2023 | 2 | — | 1 | 12 |
| 2024 | 2 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 1 | — | 1 | — |
Planning a device in NTG? 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