FDA product code · Orthopedic

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

Name: FDA decisions, review times, recalls and adverse event reports for product code KYK
Creator: 510(k) Report

KYKClass II21 CFR 888.3500510(k) required3 decisions since 19850 recalls

3 FDA decisions since 1985. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of KYK 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 · KYK

FDA has decided no KYK device since 2007.

Median 510(k) review, days · KYK

Too few KYK 510(k)s in any year since 2007 to give a median.

Recalls per year · KYK

No recall names KYK since 2007.

Adverse event reports per year · KYK

1in 2020

2007high 2 (2007) · low 0 (2009)2025

MAUDE reports naming product code KYK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — KYK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KYK? 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

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

What has FDA decided in KYK lately?