510(k) · Cleared
ClearedXenMatrix AB Surgical Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. R. Bard · PIJ Collagen Surgical Mesh Containing Drugs
Cleared on Dec 23, 2016 as substantially equivalent to K133223 (C.R. Bard, Inc., 2014) and 1 other predicate after a 141-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Dec 23, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- PIJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K921895 (1992). 124 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations between
- 3 generations backK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- 2 generations backK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- 1 generation backK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
- This deviceK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016
Show all 14 generations
- Root · 14 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 13 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 12 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 11 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 10 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 9 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 8 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 7 generations backK052830 SportmeshArtimplant AB · 2006
- 6 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 5 generations backK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
- 4 generations backK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
- 3 generations backK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- 2 generations backK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- 1 generation backK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
- This deviceK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −13 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −12 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −11 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −10 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −8 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −7 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −6 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −5 | K090271 | Hydrocoat Mesh | Promethean Surgical Devices, Inc. | 2010 | — |
| −4 | K093524 | Pivit a/B ST and Pivit a/B ST-R | Tyrx, Inc. | 2010 | — |
| −3 | K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial Coating | C.R. Bard, Inc. | 2012 | — |
| −2 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| −1 | K151177 | XenMatrix AB Surgical Graft | C. R. Bard | 2015 | — |
| 0 (this device) | K162193 | XenMatrix AB Surgical Graft | C. R. Bard | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133223 | Xenmatrix AB Surgical GraftSummary page 4…mber: 21 CFR 878.3300 Product Code: PIJ, FTM, OXH Predicate Device Names: The predicate device for this submission is XenMatrix™ AB Surgical Graft (K133223 and K151177); marketed by C. R. Bard, Inc. This predicate has not been subject to a design-related recall. The reference device… | 2014 |
| * | K151177 | XenMatrix AB Surgical GraftSummary page 4…21 CFR 878.3300 Product Code: PIJ, FTM, OXH Predicate Device Names: The predicate device for this submission is XenMatrix™ AB Surgical Graft (K133223 and K151177); marketed by C. R. Bard, Inc. This predicate has not been subject to a design-related recall. The reference device XenMatrix™ S… | 2015 |
| † | K140501 | Xenmatrix Surgical Graft | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 124 ancestors have a recall of any class.
- 1 other device also cites its predicate K133223.
How does its category compare?
All PIJ devicesPIJ Collagen Surgical Mesh Containing Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PIJ
1in 2016
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
MAUDE reports naming product code PIJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo…
Read the full statement (101 words)
The XenMatrix™ AB Surgical Graft is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162193: XenMatrix AB Surgical Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162193
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026