# K122306: Synovis Collagen Matrix (TBD)

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Mar 8, 2013 after 219 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K842066 (1985). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002233: Bvi Sling, Bio-Vascular, Inc. (2000) Summary page 1.
- K030879: Veritas Collagen Matrix, Synovis Surgical Innovations (2003) Summary page 1.
- K062915: Veritas Collagen Matrix, Synovis Surgical Innovations (2006) Summary page 1.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 1.
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.
- K961810: Supple Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K821532: Periguard Pericardial Patch, Genetic Laboratories, Inc. (1982) Summary page 1.
- K833021: Peri-Guard Pericardial Patch-Hernia, Genetic (1983) Summary page 1.
- K842066: Peri-Guard Pericardial Patch, Genetic Laboratories, Inc. (1985) Summary page 1.
- K961811: Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.
- K971726: CV Peri-Guard - Cardiovascular Patch, Bio-Vascular, Inc. (1998) Summary page 1.
- K051405: Regensis Pericardial Patch, Cormatrix Cardiovascular, Inc. (2005)

## Indications for use
Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Source page: https://510kreport.com/device/K122306
Methodology: https://510kreport.com/methodology