# K103787: Medeor Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Feb 7, 2011 after 42 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: 10 generations back to K921895 (1992). 49 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091499: Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry), Kensey Nash Corp. (2009) Summary page 1.
- K094061: Kensey Nash Ecm Surgical Patch, Kensey Nash Corporation (2010) Summary page 1.

## Most influential descendants
- K251690: Arthrex SpeedFLEX™ Implant (2025), 0 descendants of its own
- K133169: Meso Tendon Matrix (2013), 0 descendants of its own

## Indications for use
Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. The device 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. The device is intended for single use only.

Source page: https://510kreport.com/device/K103787
Methodology: https://510kreport.com/methodology