510(k) · Cleared
ClearedXylos Macro-Porous 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 Aug 25, 2011 as substantially equivalent to K083823 (Xylos Corporation, 2009) and 2 other predicates after a 79-day review. Its family tree reaches back 12 generations to 1992. 5 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K921895 (1992). 59 ancestors in all, the oldest K830889 (1983). 5 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations between
- 3 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 2 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 1 generation backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- This deviceK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · cites it directly · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- Descendant · 2 generations on · 1 of its ownK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 3 generations on · 0 of its ownK262729 TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 2 generations on · 0 of its ownK230671 Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 11 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 10 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 9 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 8 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 7 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 6 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 5 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 4 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 3 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 2 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 1 generation backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- This deviceK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · cites it directly4descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 2 generations on2descendants
- K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 2 generations on1descendant
- K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 3 generations on0descendants
- K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −11 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −10 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −9 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −8 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −6 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −5 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −4 | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | 1 |
| −3 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| −2 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| −1 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| 0 (this device) | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +1 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +2 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +3 | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +2 | K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K083823 | Securian Tissue Reinforcement MatrixSummary page 1…878.3300 Classification Status: Class 11 Product Codes: ETM Predicate Device: Xylos® Securian® Tissue Reinforcement Matrix (K083823) OrthADAPT Bicimplant (K071065), Pegasus, Parietex Composite Mesh… | 2009 |
| * | K071065 | Orthadapt BioimplantSummary page 1…Codes: ETM Predicate Device: Xylos® Securian® Tissue Reinforcement Matrix (K083823) OrthADAPT Bicimplant (K071065), Pegasus, Parietex Composite Mesh (K040998), Covidien Mersilene… | 2007 |
| * | K040998 | Modification to Parietex Composite (Pco) MeshSummary page 1…® Tissue Reinforcement Matrix (K083823) OrthADAPT Bicimplant (K071065), Pegasus, Parietex Composite Mesh (K040998), Covidien Mersilene Mesh (Pre-amendment), Ethicon Inc. Device Description: Xylos® Macro-Porou… | 2004 |
| * | — | Mersilene Mesh Named without a submission number | |
| † | K081882 | Modification to Xylos Surgical Mesh | 2008 |
| † | K090880 | Xylos Porous Surgical Mesh | 2009 |
| † | K090788 | Xylos® MTA® Protective Sheet | |
| † | K100984 | Xylos Vessel Guard | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | 2022 | 4 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 59 ancestors have a recall of any class.
- Of its descendants, K220091 (Xiros, Ltd., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K083823.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical…
Read the full statement (181 words)
Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Xylos® Macro-Porous Surgical Mesh is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Xylos® Macro-Porous Surgical Mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111584: Xylos Macro-Porous 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/K111584
Report an extraction error
Are you the manufacturer?
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