510(k) · Cleared
ClearedSecurian Tissue Reinforcement Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xylos Corporation · FTM Mesh, Surgical
Cleared on Mar 18, 2009 as substantially equivalent to K081882 (Xylos Corporation, 2008) and 3 other predicates after an 86-day review. Its family tree reaches back 11 generations to 1992. 9 later devices descend from it.
- Decided
- Mar 18, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K921895 (1992). 52 ancestors in all, the oldest K830889 (1983). 9 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 2 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 1 generation backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- This deviceK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · cites it directly · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · 2 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 3 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
- Descendant · 3 generations on · 1 of its ownK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 3 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 2 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 1 generation backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- This deviceK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · cites it directly5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 2 generations on4descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 3 generations on2descendants
- K090778Mta Protective SheetXylos Corporation · 2009 · cites it directly2descendants
- K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −3 | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | 1 |
| −2 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| −1 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| 0 (this device) | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +1 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +2 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +3 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +1 | K090778 | Mta Protective Sheet | Xylos Corporation | 2009 | — |
| +3 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
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 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (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 |
|---|---|---|---|
| * | K081882 | Modification to Xylos Surgical MeshSummary page 1…Surgical Mesh Regulatory Class: Class II Product Codes: FTM Predicate Device(s): XYLOSO Surgical Mesh, K08 1882 /XYLOS Surgical Mesh, K02323 7 Ortho-Wrapo Bio… | 2008 |
| * | K023237 | Xylos Surgical MeshSummary page 1…Product Codes: FTM Predicate Device(s): XYLOSO Surgical Mesh, K08 1882 /XYLOS Surgical Mesh, K02323 7 Ortho-Wrapo Bioresorbable Sheet, K072 190 (Ort… | 2003 |
| * | K072190 | Ortho-Wrap Bioresorbable SheetSummary page 1…urgical Mesh, K08 1882 /XYLOS Surgical Mesh, K02323 7 Ortho-Wrapo Bioresorbable Sheet, K072 190 (Ortho-Wrape Trademark of MAST Biosurgery, Inc.)… | 2008 |
| * | K021056 | PermacolSummary page 1…sorbable Sheet, K072 190 (Ortho-Wrape Trademark of MAST Biosurgery, Inc.) Permacol TM, K021056 (PermacolTm Biological Implant Trademark of Tissue… | 2002 |
What descends from it? (9)
2 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 17 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 52 ancestors have a recall of any class.
- Of its descendants, K111584 (Xylos Corporation, 2011) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K081882.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The SecurianTM Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. SecurianTM Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. SecurianTM Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by sutures or suture anchors during…
Read the full statement (169 words)
The SecurianTM Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. SecurianTM Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. SecurianTM Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SecurianTM Tissue Reinforcement Matrix 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. SecurianTM Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. SecurianTM Tissue Reinforcement Matrix is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083823: Securian Tissue Reinforcement Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083823
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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