# K083823: Securian Tissue Reinforcement Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Mar 18, 2009 after 86 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921895 (1992). 52 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081882: Modification to Xylos Surgical Mesh, Xylos Corporation (2008) Summary page 1.
- K023237: Xylos Surgical Mesh, Xylos Corporation (2003) Summary page 1.
- K072190: Ortho-Wrap Bioresorbable Sheet, Mast Biosurgery (2008) Summary page 1.
- K021056: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.

## Most influential descendants
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own
- K090778: Mta Protective Sheet (2009), 2 descendants of its own
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own

## Indications for use
The SecurianTM Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. SecurianTM Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. SecurianTM Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SecurianTM Tissue Reinforcement Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. SecurianTM Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. SecurianTM Tissue Reinforcement Matrix is intended for one-time use.

Source page: https://510kreport.com/device/K083823
Methodology: https://510kreport.com/methodology