# K062915: Veritas Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Dec 6, 2006 after 70 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842066 (1985). 39 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030879: Veritas Collagen Matrix, Synovis Surgical Innovations (2003) Summary page 1.
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration, Synovis Surgical Innovations (2004) Summary page 1.
- K002699: Parietex Composite (Pco) Mesh, Medical Device Consultants, Inc. (2001) Summary page 1.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes, Sofradim Production (2005) Summary page 1.
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003) Summary page 1.
- K992189: Gore-Tex Dualmesh Biomaterial, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh, Genzyme Corp. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K002233: Bvi Sling, Bio-Vascular, Inc. (2000). 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.

## Most influential descendants
- K073391: Surgisis Biodesign Tissue Graft (2008), 8 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), 2 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own

## Recalls of this device
- Dec 11, 2020 · Class II · Z-0807-2021: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

## Indications for use
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.

Source page: https://510kreport.com/device/K062915
Methodology: https://510kreport.com/methodology