FDA product code · Orthopedic
Prosthesis, Finger, Semi-Constrained, Metal/Polymer
1 FDA decision since 2025. No recall names this code.
A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SFA 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 · SFA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFA
Too few SFA 510(k)s in any year since 2007 to give a median.
Recalls per year · SFA
No recall names SFA since 2007.
Adverse event reports per year · SFA
34in 2025
MAUDE reports naming product code SFA, 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 4 | — | 0 | 34 |
| 2026 | 3 | — | 0 | — |
Planning a device in SFA? 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