# K071887: Sportmesh or Artelon Tissue Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Artimplant AB
- Decided: Sep 18, 2007 after 71 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 8 generations back to K921895 (1992). 34 ancestors in all.
28 later devices descend from it; 6 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042809: Cuffpatch, Organogenesis, Inc. (2004) Summary page 1.
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007) Summary page 1.
- K053562: Zimmer Collagen Repair Patch, Tissue Science Laboratories, Plc (2006) Summary page 1.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 1.

## Most influential descendants
- K192112: FlexBand Plus (2019), 9 descendants of its own
- K083307: Synthasome X-Repair (2009), 9 descendants of its own
- K090271: Hydrocoat Mesh (2010), 6 descendants of its own
- K121216: STR Graft (2012), 5 descendants of its own
- K093524: Pivit a/B ST and Pivit a/B ST-R (2010), 5 descendants of its own

## Indications for use
SportMesh TM / Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. SportMesh TM / Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. SportMeshTM'/ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. SportMesh TM / Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Source page: https://510kreport.com/device/K071887
Methodology: https://510kreport.com/methodology