510(k) Report

FDA product code · General and plastic surgery

Collagen Surgical Mesh Containing Drugs

PIJClass II21 CFR 878.3300510(k) required3 decisions since 20140 recalls

3 FDA decisions since 2014. No recall names this code. The most-cited predicate is K133223, named by 2 later devices.

Reinforcement of soft tissue where weakness exists.

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, general and plastic surgery panel

Twenty years of PIJ 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 · PIJ

1in 2016

2014: 12015: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIJ

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

Recalls per year · PIJ

No recall names PIJ since 2007.

Adverse event reports per year · PIJ

4in 2025

2016: 52017: 112018: 172019: 42020: 92021: 62022: 142023: 42024: 32025: 4
2007high 17 (2018) · low 0 (2007)2025

MAUDE reports naming product code PIJ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20151—00
20161—05
20170—011
20180—017
20190—04
20200—09
20210—06
20220—014
20230—04
20240—03
20250—04
20260—0—
FIG. 1 — PIJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PIJ? 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 predicates do PIJ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 20142cite it
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 20151cites it

Which PIJ devices have the deepest lineage?

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

  • K162193XenMatrix AB Surgical GraftC. R. Bard · 201614generations
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 201513generations
  • K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 201412generations

What has FDA decided in PIJ lately?

  • K162193XenMatrix AB Surgical GraftC. R. Bard · 2016
  • K151177XenMatrix AB Surgical GraftC. R. Bard · 2015
  • K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014

All 3 PIJ decisions →

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