# K111584: Xylos Macro-Porous Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Aug 25, 2011 after 79 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: 12 generations back to K921895 (1992). 59 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083823: Securian Tissue Reinforcement Matrix, Xylos Corporation (2009) Summary page 1.
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007) Summary page 1.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- (no number) Mersilene Mesh: named in the summary without a submission number

## Most influential descendants
- 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
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own
- K262729: TeKBrace Solo Soft Tissue Reinforcement Device (2026), 0 descendants of its own
- K230671: Pitch PaSoft Tissue Reinforcement Device (2023), 0 descendants of its own

## Indications for use
Xylos® Macro-Porous Surgical Mesh is intended to be used for implantation to reinforce and protect soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Xylos® Macro-Porous Surgical Mesh is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Xylos® Macro-Porous Surgical Mesh 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. Xylos® Macro-Porous Surgical Mesh is indicated for open and endoscopic procedures and is intended for one-time use only.

Source page: https://510kreport.com/device/K111584
Methodology: https://510kreport.com/methodology