510(k) Report

FDA product code · Orthopedic

Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament

QWJClass II21 CFR 878.3300510(k) required1 decision since 20260 recalls

1 FDA decision since 2026. No recall names this code.

For reinforcement of soft tissue where weakness exists in ligament repair

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 QWJ 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 · QWJ

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QWJ

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

Recalls per year · QWJ

No recall names QWJ since 2007.

Adverse event reports per year · QWJ

No MAUDE report names QWJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—
FIG. 1 — QWJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QWJ? 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

Which QWJ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K260317Artelon Convenience KitsInternational Life Sciences · 202615generations

What has FDA decided in QWJ lately?

  • K260317Artelon Convenience KitsInternational Life Sciences · 2026

The one QWJ decision →

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