# K060367: Tenolig

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Aug 9, 2006 after 177 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). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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 1.
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.

## Most influential descendants
- K080974: TLS Fixation System (2008), 2 descendants of its own
- K120740: Cols® Fixation System (2013), 0 descendants of its own
- K113591: Cols Peek (2011), 0 descendants of its own

## Indications for use
TENOLIG® is indicated for surgical repair of Achilles tendon ruptures by percutaneous approach

Source page: https://510kreport.com/device/K060367
Methodology: https://510kreport.com/methodology