# K201427: Trivergent Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Benvenue Medical, Inc.
- Decided: Oct 21, 2020 after 145 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K990745 (1999). 114 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171838: TiLock2 Spinal System, Genesys Spine (2017) Summary page 4.

## Most influential descendants
- K253169: Duet™ Spinal Fixation System (2026), 1 descendant of its own
- K262712: Duet™ Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The Trivergent Spinal Fixation System is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K201427
Methodology: https://510kreport.com/methodology