# K091499: Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Oct 22, 2009 after 154 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: 9 generations back to K921895 (1992). 46 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061030: Bioblanket Surgical Mesh, Kensey Nash Corporation (2006) Summary page 1.
- K080353: LTM-T Surgical Mesh, Lifecell Corp. (2008) Summary page 1.

## Most influential descendants
- K103787: Medeor Matrix (2011), 2 descendants of its own
- 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; urogynecological surgical reinforcement (excluding transvaginal repair of pelvic organ prolapse) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), 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. Medeor 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. Medeor Matrix is intended for one time use.

Source page: https://510kreport.com/device/K091499
Methodology: https://510kreport.com/methodology