# K042453: Modification to Equation Fixation System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Oct 7, 2004 after 27 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 1 generation back to K013962 (2002). 1 ancestor in all.
898 later devices descend from it; 3 cite it directly.
1 of 900 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013962: Equation Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 2.

## Most influential descendants
- K042962: Modification to CD Horizon Spinal System (2004), 897 descendants of its own
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K052187: Modification to:  CD Horizon Spinal System (2005), 780 descendants of its own
- K082236: CD Horizon Spinal System (2008), 779 descendants of its own

## Indications for use
The EQUATION TM Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATIONT M Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the EQUATION TM Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-SI) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K042453
Methodology: https://510kreport.com/methodology