510(k) · Cleared
ClearedModification to Xylos Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xylos Corporation · FTM Mesh, Surgical
Cleared on Jul 11, 2008 as substantially equivalent to K023237 (Xylos Corporation, 2003) after a 9-day review. Its family tree reaches back 4 generations to 1985. 11 later devices descend from it.
- Decided
- Jul 11, 2008
- Review
- 9 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K842066 (1985). 9 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 1 generation backK023237 Xylos Surgical MeshXylos Corporation · 2003
- This deviceK081882 Modification to Xylos Surgical MeshXylos Corporation · 2008
- Descendant · cites it directly · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · 2 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · 3 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- Descendant · cites it directly · 2 of its ownK090778 Mta Protective SheetXylos Corporation · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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
- K090778Mta Protective SheetXylos Corporation · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −3 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −1 | K023237 | Xylos Surgical Mesh | Xylos Corporation | 2003 | — |
| 0 (this device) | K081882 | Modification to Xylos Surgical Mesh | Xylos Corporation | 2008 | — |
| +1 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +2 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +3 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +4 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +1 | K090778 | Mta Protective Sheet | Xylos Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K023237 | Xylos Surgical MeshSummary page 1…n Name: Surgical Mesh Classification Status: Class II Product Codes: FTM Predicate Device: XYLOS Surgical Mesh (K023237) Device Description: The XYLOS Surgical Mesh will function as a non-absorbable surgical biomnaterial that enables rapid fixation… | 2003 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K083823 (Xylos Corporation, 2009) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K023237.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 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.
https://510kreport.com/device/K081882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081882: Modification to Xylos Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081882
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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