# K082535: Covidien Sports Surgery as Meniscal Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Devices, A Global Business Unit Covidien
- Decided: Dec 1, 2008 after 90 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925573 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930591: TI-Cron and Dacron Sutures, Davis & Geck, Inc. (1993) Summary page 1.
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems, Smith & Nephew, Inc. (2007) Summary page 1.
- K032901: Stryker Mini-Mender Meniscal Repair System, Stryker Endoscopy (2003) Summary page 1.

## Indications for use
The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear Injuries

Source page: https://510kreport.com/device/K082535
Methodology: https://510kreport.com/methodology