FDA product code · Orthopedic
Knee Arthroplasty Implantation System
2 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 209 days (half between 179 and 238). 3 recalls name this code, 0 of them Class I.
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OOG 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 · OOG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OOG
Too few OOG 510(k)s in any year since 2007 to give a median.
Recalls per year · OOG
3in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOG
34in 2025
MAUDE reports naming product code OOG, 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 | 6 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 3 | 30 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
Planning a device in OOG? 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) ReportRelated product codes
Other codes under 21 CFR 888.3560.