# K171680: Infinity-Lock 3, Infinity-Lock 5

- Pathway: 510(k) (Special)
- Applicant: Xiros, Ltd.
- Decided: Jun 30, 2017 after 24 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: 1 generation back to K002172 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002172: Poly-Tapes (Various Sizes and Woven Construction Variants), Xiros Plc (2001) Summary page 4.

## Indications for use
The Infinity-Locks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.

Source page: https://510kreport.com/device/K171680
Methodology: https://510kreport.com/methodology