510(k) · Cleared
Recalled · Class II · 2019Cormatrix Protect Ecm Envelope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cormatrix Cardiovascular, Inc. · FTM Mesh, Surgical
Cleared on Aug 15, 2014 as substantially equivalent to K063091 (Tyrx Pharma, Inc., 2008) and 6 other predicates after a 189-day review. Its family tree reaches back 10 generations to 1985. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2014
- Review
- 189 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 10 generations to K842066 (1985). 81 ancestors in all, the oldest K810428 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations between
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- 1 generation backK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
- This deviceK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 1 of its ownK192616 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK201313 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 7 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 6 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 5 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- 1 generation backK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
- This deviceK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · cites it directly3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 2 generations on2descendants
- K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2019 · 3 generations on1descendant
- K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −9 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −7 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −6 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −5 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −2 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| −1 | K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | 2008 | — |
| 0 (this device) | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | — |
| +1 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +2 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
| +3 | K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2019 | — |
| +4 | K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (7)
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 |
|---|---|---|---|
| * | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Summary page 4…FTM, Class II Predicate Devices The CorMatrix® PROTECT ECM® Envelope is substantially equivalent to the following devices: • TyRx AIGISRx Antibacterial Envelope, K063091 • TyRx AIGISRx R Fully Resorbable Antibacterial Envelope, K130943 • CorMatrix ECM for Cardiac Tissue Repair, K06334… | 2008 |
| * | K130943 | Aigis RX R PM/ Aigis RX R IcdSummary page 4…substantially equivalent to the following devices: • TyRx AIGISRx Antibacterial Envelope, K063091 • TyRx AIGISRx R Fully Resorbable Antibacterial Envelope, K130943 • CorMatrix ECM for Cardiac Tissue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 •… | 2013 |
| * | K063349 | Cormatrix Patch for Cardiac Tissue RepairSummary page 4…TyRx AIGISRx Antibacterial Envelope, K063091 • TyRx AIGISRx R Fully Resorbable Antibacterial Envelope, K130943 • CorMatrix ECM for Cardiac Tissue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 • Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair… | 2007 |
| * | K980431 | SurgisisSummary page 4…TyRx AIGISRx R Fully Resorbable Antibacterial Envelope, K130943 • CorMatrix ECM for Cardiac Tissue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 • Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device, K062697 and K073391 Device Description The C… | 1998 |
| * | K062696 | Surgisis, Surgisis ESSummary page 4…Rx R Fully Resorbable Antibacterial Envelope, K130943 • CorMatrix ECM for Cardiac Tissue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 • Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device, K062697 and K073391 Device Description The CorMatrix PRO… | 2006 |
| * | K062697 | Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftSummary page 4…Cardiac Tissue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 • Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device, K062697 and K073391 Device Description The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic… | 2006 |
| * | K073391 | Surgisis Biodesign Tissue GraftSummary page 4…sue Repair, K063349 • Cook Biotech SurgiSIS Surgical Mesh, K980431 and K062696 • Cook Biotech Biodesign Tissue Graft, SIS Hernia Repair Device, K062697 and K073391 Device Description The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)… | 2017 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2019 | Class II | Z-0039-2020 | Under Investigation by firm | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. |
| Aug 21, 2019 | Class II | Z-0040-2020 | Under Investigation by firm | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 10 of the 81 ancestors have a recall of any class.
- Of its descendants, K173242 (Aziyo Biologics, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K063091.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140306: Cormatrix Protect Ecm Envelope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140306
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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