510(k) · Cleared
ClearedMta Protective Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xylos Corporation · FTM Mesh, Surgical
Cleared on Apr 28, 2009 as substantially equivalent to K081882 (Xylos Corporation, 2008) and 2 other predicates after a 36-day review. Its family tree reaches back 12 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 36 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K921895 (1992). 53 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 2 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 deviceK090778 Mta Protective SheetXylos Corporation · 2009
- Descendant · cites it directly · 0 of its ownK100313 Hydrofix Surgical SheetMimedx Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK100984 Xylos Vessel GuardXylos Corporation · 2010
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 deviceK090778 Mta Protective SheetXylos Corporation · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K090778 | Mta Protective Sheet | Xylos Corporation | 2009 | — |
| +1 | K100313 | Hydrofix Surgical Sheet | Mimedx Group, Inc. | 2011 | — |
| +1 | K100984 | Xylos Vessel Guard | Xylos Corporation | 2010 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081882 | Modification to Xylos Surgical MeshSummary page 1…Surgical Mesh Regulatory Class: Class 11 Product Codes: FTM Predicate Device(s): XYLOS® Surgical Mesh, K081 882 MAST Biosurgery Ortho-Wrap Tm Bioresorbable Sheet, K072190… | 2008 |
| * | K072190 | Ortho-Wrap Bioresorbable SheetSummary page 1…e(s): XYLOS® Surgical Mesh, K081 882 MAST Biosurgery Ortho-Wrap Tm Bioresorbable Sheet, K072190 (Ortho-Wrap TM is a Trademark of MAST Biosurgery, Inc.) Device Description: MTA Protective Sh… | 2008 |
| * | K083823 | Securian Tissue Reinforcement MatrixSummary page 2…l Equivalence: The MTA Protective Sheet is biocompatible since it is biologically and chemically identical to Securian Tissue Reinforcement Matrix previously cleared in K083823 and very similarly manufactured. In addition, the MTA Protective Sheet has similar indications for use to Securian Tissue Reinfor… | 2009 |
What descends from it? (2)
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 53 ancestors have a recall of any class.
- Of its descendants, K100313 (Mimedx Group, Inc., 2011) has gone furthest, with 0 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 MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090778: Mta Protective Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090778
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