# K251131: Annex® 2 Adjacent Level System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 6, 2025 after 56 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: 22 generations back to K853033 (1985). 225 ancestors in all.
No later device cites it as a predicate yet.
1 of 226 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132403: Annextm Adjacent Level System, Spine Wave, Inc. (2014) Summary page 5.
- K240685: Salvo® Spine System, Spine Wave, Inc. (2024) Summary page 5.

## Indications for use
When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

Source page: https://510kreport.com/device/K251131
Methodology: https://510kreport.com/methodology