# K203385: TenoTac Soft Tissue Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Feb 11, 2021 after 85 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: 6 generations back to K904436 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182898: TenoTac Soft Tissue Fixation System, Paragon 28, Inc. (2019) Summary page 4.

## 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® device include: Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux valgus repair, hallux malleus repair and reconstruction, metatarsal ligament/tendon repair and reconstruction including plantar plate attenuation and tear, and the correction of hammer toe, claw toe, mallet toe, crossover toe, floating toe, and any other lesser toe deformities, correction of metatarsophalangeal joint instability due to shortening from interphalangeal fusion, correction of metatarsophalangeal joint instability due to shortening from Weil osteotomy, Achilles tendon repair. Hand & Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, tendon transfers in phalanx, Volar plate reconstruction.

Source page: https://510kreport.com/device/K203385
Methodology: https://510kreport.com/methodology