510(k) Report

510(k) · Cleared

Cleared

Xylos Surgical Mesh

K023237510(k) TraditionalCleared Mar 18, 2003172-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xylos Corporation · FTM Mesh, Surgical

Cleared on Mar 18, 2003 as substantially equivalent to K983162 (Bio-Vascular, Inc., 1998) and 2 other predicates after a 172-day review. Its family tree reaches back 3 generations to 1985. 12 later devices descend from it.

Decided
Mar 18, 2003
Review
172 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K842066 (1985). 8 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 2 other ancestors1992: 2 other ancestors2008: 1 descendant cleared2009: 3 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants clearedK842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 1985K961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K983162 · Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc · Bio-Vascular, Inc. · 1998 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K983162 · Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc · Bio-Vascular, Inc. · 1998 · recalledK961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 19850+5
  1. Root · 3 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
  2. 2 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 1 generation backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
  4. This deviceK023237 Xylos Surgical MeshXylos Corporation · 2003
  5. Descendant · cites it directly · 11 of its ownK081882 Modification to Xylos Surgical MeshXylos Corporation · 2008
  6. Descendant · cites it directly · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
  7. Descendant · 2 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
  8. Descendant · 3 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
  9. Descendant · 4 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32010: 12011: 22022: 12023: 12025: 12026: 2
2008high 3 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all
  • K081882Modification to Xylos Surgical MeshXylos Corporation · 2008 · cites it directly11descendants
  • K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · cites it directly9descendants
  • K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · 2 generations on5descendants
  • K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 3 generations on4descendants
  • K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K842066Peri-Guard Pericardial PatchGenetic Laboratories, Inc.1985—
−2K961811Peri-Guard PericardiumBio-Vascular, Inc.1996—
−1K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19982
0 (this device)K023237Xylos Surgical MeshXylos Corporation2003—
+1K081882Modification to Xylos Surgical MeshXylos Corporation2008—
+1K083823Securian Tissue Reinforcement MatrixXylos Corporation2009—
+2K111584Xylos Macro-Porous Surgical MeshXylos Corporation2011—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.2022—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199620
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201010
201120
202210
202310
202510
202620
FIG. 1 — Lineage of K023237, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FTM device

  1. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…
Summary page 1
…t Code/Classification Number: FTM (878.3300) Regulatory Class: II PREDICATE DEVICES: Bio-Vascular, Inc. Peri-Guard@Pericardium K983162 Ethicon, Inc. Prolene Polypropylene Mesh, Nonabsorbable K962530 XYLOSTMXCellB Wound Dressing K974251 STATEMENT OF SU…
Bio-Vascular, Inc.19982
*K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh
Summary page 1
…ass: II PREDICATE DEVICES: Bio-Vascular, Inc. Peri-Guard@Pericardium K983162 Ethicon, Inc. Prolene Polypropylene Mesh, Nonabsorbable K962530 XYLOSTMXCellB Wound Dressing K974251 STATEMENT OF SUBSTANTIAL EQUIVALENCE: XYLOSTMSurgical Mesh is substantially equi…
ETHICON, Inc.1996—
*K974251X-Cell Wound Dressing
Summary page 1
…DEVICES: Bio-Vascular, Inc. Peri-Guard@Pericardium K983162 Ethicon, Inc. Prolene Polypropylene Mesh, Nonabsorbable K962530 XYLOSTMXCellB Wound Dressing K974251 STATEMENT OF SUBSTANTIAL EQUIVALENCE: XYLOSTMSurgical Mesh is substantially equivalent to the predicate devices, having sim…
Xylos Corporation1998—

Also cleared against K983162: 12 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081882Modification to Xylos Surgical MeshXylos Corporation200811
K083823Securian Tissue Reinforcement MatrixXylos Corporation20099

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 18 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K081882 (Xylos Corporation, 2008) has gone furthest, with 11 descendants of its own.
  • 12 other devices also cite its predicate K983162.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

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

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—0—

What is it indicated for?

This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Indications for use as stated in the FDA summary.

Also cleared against K983162

12 other devices cite the same predicate.

  • K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc. · 20234 recalls
  • K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc. · 2015
  • K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
  • K043366Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
  • K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
  • K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc. · 2004

More from Xylos Corporation

9 FDA decisions under this applicant name. See the company

  • K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
  • K100984Xylos Vessel GuardXylos Corporation · 2010
  • K090880Xylos Porous Surgical MeshXylos Corporation · 2009
  • K090778Mta Protective SheetXylos Corporation · 2009
  • K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009

Recent decisions in FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
  • K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K023237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023237: Xylos Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023237

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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