510(k) · Cleared
ClearedVeritas Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Surgical Innovations · OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Cleared on Apr 24, 2003 after a 35-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 18 later devices descend from it.
- Decided
- Apr 24, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- OXE
- Recalls
- None
- Predicates
- 1
18 later devices descend from it, 4 citing it directly.
- This deviceK030879 Veritas Collagen MatrixSynovis Surgical Innovations · 2003
- Descendant · cites it directly · 15 of its ownK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK073391 Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
- Descendant · cites it directly · 4 of its ownK041669 Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 2004 · Recalled
- Descendant · 4 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K062915Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · cites it directly15descendants
- K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc. · 2008 · 2 generations on8descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 3 generations on4descendants
- K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 2004 · cites it directly4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030879 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2003 | — |
| +1 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| +2 | K073391 | Surgisis Biodesign Tissue Graft | Cook Biotech, Inc. | 2008 | — |
| +3 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +1 | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD | Synovis Surgical Innovations | 2004 | 8 |
| +4 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 OXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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…00 Fax: 651-642-9018 Fonda Burley At address above Veritas Collagen Matrix Surgical Mesh Mesh, Surgical 21 CFR 878.3300 v, OXE, OB, oWV, AT Veritas Collagen Matrix, K002233 An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary pr… | 2000 |
What descends from it? (18)
See all 184 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?
- Of its descendants, K062915 (Synovis Surgical Innovations, 2006) has gone furthest, with 15 descendants of its own.
How does its category compare?
All OXE devicesOXE Mesh, Surgical, Collagen, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXE
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OXE
Too few OXE 510(k)s in any year since 2007 to give a median.
Recalls per year · OXE
No recall names OXE since 2007.
Adverse event reports per year · OXE
No MAUDE report names OXE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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, Ilobectomy, bullectomy, bronchial resection, segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus. Reinforcement of the gastric staple…
Read the full statement (108 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, Ilobectomy, bullectomy, bronchial resection, segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line 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).
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/K030879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030879: Veritas Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030879
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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