# K132403: Annextm Adjacent Level System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jan 10, 2014 after 162 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 14 generations back to K853033 (1985). 193 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070245: Capsure Pedicle Screw System, Spine Wave, Inc. (2007) Summary page 1.
- K132154: Capsure PS System, Spine Wave, Inc. (2013). Cleared while this submission was under review Summary page 1.
- K122226: Revere Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K251131: Annex® 2 Adjacent Level System (2025), 0 descendants of its own
- K232719: ProMIS Extension Rod System (2023), 0 descendants of its own

## Indications for use
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex h Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Annex h Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-SI vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained. The Annexm Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure®1 or Sniper(1) Spine Systems.

Source page: https://510kreport.com/device/K132403
Methodology: https://510kreport.com/methodology