510(k) · Cleared
Recalled · Class II · 2020Veritas Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Surgical Innovations · FTM Mesh, Surgical
Cleared on Dec 6, 2006 as substantially equivalent to K030879 (Synovis Surgical Innovations, 2003) and 7 other predicates after a 70-day review. Its family tree reaches back 8 generations to 1985. 15 later devices descend from it. It has been recalled once.
- Decided
- Dec 6, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 8 generations to K842066 (1985). 39 ancestors in all, the oldest K810428 (1981). 15 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 5 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 4 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 3 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- This deviceK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006
- Descendant · cites it directly · 8 of its ownK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008 · cites it directly8descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 2 generations on4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 3 generations on3descendants
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 4 generations on2descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −7 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −5 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −4 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −3 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| 0 (this device) | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | — |
| +1 | K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | 2008 | — |
| +2 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +3 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
| +4 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo… | Aziyo Biologics, Inc. | 2018 | 1 |
| +2 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K002233 | FDA’s K002233 is Bvi Sling Our OCR of the scanned summary read K002233, FDA’s number for Bvi Sling (Bio-Vascular, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Veritas® Collagen Matrix”. Kept off the family tree. Summary page 1…ss above Device Trade Name: Veritas® Collagen Matrix Common Name Surgical Mesh Classification Name Mesh, Surgical 878.3300 Predicate devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K05… | 2000 |
| * | K030879 | Veritas Collagen MatrixSummary page 1…Device Trade Name: Veritas® Collagen Matrix Common Name Surgical Mesh Classification Name Mesh, Surgical 878.3300 Predicate devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 Macr… | 2003 |
| * | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Summary page 1…e Name: Veritas® Collagen Matrix Common Name Surgical Mesh Classification Name Mesh, Surgical 878.3300 Predicate devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-… | 2004 |
| * | K002699 | Parietex Composite (Pco) MeshSummary page 1…878.3300 Predicate devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpra… | 2001 |
| * | K040998 | Modification to Parietex Composite (Pco) MeshSummary page 1…Predicate devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpramesh™ [P,… | 2004 |
| * | K050187 | Parietex Composite Pco-OS and Pco-OB MeshesSummary page 1…te devices Veritas® Collagen Matrix K002233, K030879 and K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpramesh™ [P, K040868… | 2005 |
| * | K031955 | Macropore Surgi-Wrap Mast Bioresorbable SheetSummary page 1…d K040119 Synovis Surgical Innovations (Acting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpramesh™ [P, K040868 Device Description An implantable surgical patch comp… | 2003 |
| * | K992189 | Gore-Tex Dualmesh BiomaterialSummary page 1…ting as its own predicate.) PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpramesh™ [P, K040868 Device Description An implantable surgical patch comprised of non-crosslinked bovine pericardiu… | 1999 |
| * | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent MeshSummary page 1…IETEX® COMPOSITE Mesh, K002699, K040998, K050187 MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955 GORE-TEX® Dualmesh® Biomaterial, K992189 Genzyme Serpramesh™ [P, K040868 Device Description An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix unde… | 2004 |
What descends from it? (15)
See all 155 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2020 | Class II | Z-0807-2021 | Process design | VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K073391 (Cook Biotech, Inc., 2008) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K030879.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies; this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy. pnuemonectomylpneumectomy, pneumoreductlon) and other incision and excision of the lung and bronchus. Remforcement of the gastric staple…
Read the full statement (124 words)
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies; this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy. pnuemonectomylpneumectomy, pneumoreductlon) and other incision and excision of the lung and bronchus.
Remforcement of the gastric staple fine during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062915: Veritas Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062915
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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