FDA product code · Orthopedic

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

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

NJDClass II21 CFR 888.3535510(k) required5 decisions since 20140 recalls

5 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 68 days (half between 63 and 101). No recall names this code. The most-cited predicate is K133811, named by 5 later devices.

Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

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 NJD 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 · NJD

1in 2025

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NJD

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

Recalls per year · NJD

No recall names NJD since 2007.

Adverse event reports per year · NJD

4in 2025

2007high 61 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	2
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	5
2022	1	—	34
2023	0	—	61
2024	1	—	14
2025	1	—	4
2026	0	—	—

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

Planning a device in NJD? 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, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Which predicates do NJD devices cite most?

Which NJD devices have the deepest lineage?

What has FDA decided in NJD lately?