# K182898: TenoTac Soft Tissue Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jan 14, 2019 after 90 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904436 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 4.

## Most influential descendants
- K203385: TenoTac Soft Tissue Fixation System (2021), 0 descendants of its own

## Indications for use
The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® include: - Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Source page: https://510kreport.com/device/K182898
Methodology: https://510kreport.com/methodology