# K013962: Equation Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 20, 2002 after 199 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
No predicates in its family tree.
900 later devices descend from it; 4 cite it directly.
1 of 901 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CD HORIZON Spinal System: named in the summary without a submission number

## Most influential descendants
- K042453: Modification to Equation Fixation System (2004), 898 descendants of its own
- 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

## Indications for use
The EQUATIOWMFixation 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 EQUATIOWMFixation 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 EQUATIONTMFixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) 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 ksion mass.

Source page: https://510kreport.com/device/K013962
Methodology: https://510kreport.com/methodology