510(k) Report

FDA product code · Orthopedic

Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

LZJClass U510(k) required11 decisions since 19891 recall

11 FDA decisions since 1989. 1 recall names this code; it is not Class I. The most-cited predicate is K072251, named by 2 later devices.

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 LZJ 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 · LZJ

1in 2014

2008: 12010: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZJ

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

Recalls per year · LZJ

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZJ

1in 2024

2007: 32008: 42009: 32010: 32012: 12013: 22014: 32015: 52016: 42017: 22018: 112019: 32020: 12021: 22022: 12023: 72024: 1
2007high 11 (2018) · low 0 (2011)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20081—04
20090—03
20101—03
20110—00
20120—01
20130—02
20141—13
20150—05
20160—04
20170—02
20180—011
20190—03
20200—01
20210—02
20220—01
20230—07
20240—01
20250—00
20260—0—
FIG. 1 — LZJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LZJ? 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