# K133287: Presson Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Feb 25, 2014 after 123 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: 6 generations back to K040583 (2004). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061577: Ovaltwist Pedicle Screw System, Signus Medizintechnik GmbH (2006) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K081080: TSRH Spinal System, Medtronic Sofamor Danek (2008) Summary page 1.
- K992920: Ebi Spinelink System, Ebi, L.P. (1999) Summary page 1.
- K083028: Modification to: Nuvasive Spherx II System, Nuvasive, Inc. (2008) Summary page 1.

## Most influential descendants
- K160820: PressON Pro Spinal Fixation System (2016), 0 descendants of its own

## Indications for use
The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K133287
Methodology: https://510kreport.com/methodology