# K133169: Meso Tendon Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation Dba Dsm Biomedical
- Decided: Dec 20, 2013 after 64 days
- Product code: OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon)
- 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). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103787: Medeor Matrix, Kensey Nash Corp. (2011) Summary page 1.

## Indications for use
Mesa Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Mesa Tendon 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. Mesa Tendon Matrix is supplied sterile and for one time use.

Source page: https://510kreport.com/device/K133169
Methodology: https://510kreport.com/methodology