# K052830: Sportmesh

- Pathway: 510(k) (Traditional)
- Applicant: Artimplant AB
- Decided: Jan 19, 2006 after 106 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: 7 generations back to K921895 (1992). 29 ancestors in all.
44 later devices descend from it; 6 cite it directly.
0 of 74 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.
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.
- (no number) Marlex Mesh: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K020256: Unicem, 3M Espe AG Dental Products (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K192112: FlexBand Plus (2019), 9 descendants of its own
- K083307: Synthasome X-Repair (2009), 9 descendants of its own

## Indications for use
SportmeshTM is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. SportmeshTM is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. SportmeshTM is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. 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. SportmeshTM reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.

Source page: https://510kreport.com/device/K052830
Methodology: https://510kreport.com/methodology