# K220219: PERMALOOP Suture, PERMATAPE Suture

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Apr 26, 2022 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: 3 generations back to K010673 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162247: Permatape, Medos International SARL (2016) Summary page 5.

## Indications for use
The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue. The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.

Source page: https://510kreport.com/device/K220219
Methodology: https://510kreport.com/methodology