510(k) · Cleared
ClearedHydrofix Surgical Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mimedx Group, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jun 14, 2011 as substantially equivalent to K072190 (Mast Biosurgery, 2008) and 1 other predicate after a 495-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Jun 14, 2011
- Review
- 495 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K921895 (1992). 54 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations between
- 3 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 2 generations backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- 1 generation backK090778 Mta Protective SheetXylos Corporation · 2009
- This deviceK100313 Hydrofix Surgical SheetMimedx Group, Inc. · 2011
Show all 13 generations
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 12 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 10 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 9 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 8 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 7 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 6 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 5 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 4 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 3 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 2 generations backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- 1 generation backK090778 Mta Protective SheetXylos Corporation · 2009
- This deviceK100313 Hydrofix Surgical SheetMimedx Group, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −12 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −10 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −9 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −7 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −6 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −5 | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | 1 |
| −4 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| −3 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| −2 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| −1 | K090778 | Mta Protective Sheet | Xylos Corporation | 2009 | — |
| 0 (this device) | K100313 | Hydrofix Surgical Sheet | Mimedx Group, Inc. | 2011 | — |
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 |
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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072190 | Ortho-Wrap Bioresorbable SheetSummary page 2…vice in case of direct contact with the tissues. Substantially Equivalent Device(s): The following are substantially equivalent predicate devices. K072 190 Mast Biosurgery, Ortho-Wrap BioresorbableSheet K090778 Xylos Corporation,MTA Protective Sheet The MiMedx Group HydroFixTM… | 2008 |
| * | K090778 | Mta Protective SheetSummary page 2…= Substantially Equivalent Device(s): The following are substantially equivalent predicate devices. K072 190 Mast Biosurgery, Ortho-Wrap BioresorbableSheet K090778 Xylos Corporation,MTA Protective Sheet The MiMedx Group HydroFixTM Surgical Sheet was shown to be substantially equivalent to pr… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 54 ancestors have a recall of any class.
- 2 other devices also cite its predicate K072190.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MiMedx HydroFix TM Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100313: Hydrofix Surgical Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100313
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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