510(k) · Cleared
ClearedVeritas Collagen Matrix (Dry)
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 Nov 26, 2008 as substantially equivalent to K041669 (Synovis Surgical Innovations, 2004) and 1 other predicate after a 43-day review. Its family tree reaches back 9 generations to 1985. 2 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K842066 (1985). 45 ancestors in all, the oldest K810428 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations between
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK083039 Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
- Descendant · cites it directly · 1 of its ownK192615 Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip…Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019
- Descendant · 2 generations on · 0 of its ownK213125 PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021
Show all 9 generations
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 1 generation backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- This deviceK083039 Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
Most influential descendants
Showing 2 of 2 · See all- K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019 · cites it directly1descendant
- K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −8 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −6 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −5 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −1 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| 0 (this device) | K083039 | Veritas Collagen Matrix (Dry) | Synovis Surgical Innovations | 2008 | — |
| +1 | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology… | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019 | — |
| +2 | K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with… | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021 | — |
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 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSummary page 1…Mesh, Surgical 21 CFR 878.3300 Product Code: FTM Predicate devices Veritas® Collagen Matrix (Dry) K041669 and Veritas® Collagen Matrix (Wet) K062915 (Device acting as its own pr… | 2004 |
| * | K062915 | Veritas Collagen MatrixSummary page 1…Product Code: FTM Predicate devices Veritas® Collagen Matrix (Dry) K041669 and Veritas® Collagen Matrix (Wet) K062915 (Device acting as its own predicate.) Device Description Veritas Collagen Matrix is an im… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | 2019 | 1 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 9 of the 45 ancestors have a recall of any class.
- Of its descendants, K192615 (Synovis Life Technologies, Inc. (Baxter International Inc.), 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K041669.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Veritas Collagen Matrix (Dry) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.
Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083039: Veritas Collagen Matrix (Dry).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083039
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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