# K033495: Modification to Equation Fixation System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Dec 3, 2003 after 28 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
No predicates in its family tree.
101 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have 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) EQUATION TM1 Fixation System: named in the summary without a submission number

## Most influential descendants
- K072022: Valeo Pedicle Screw Spinal System (2007), 100 descendants of its own
- K121115: M.U.S.T Pedicle Screw System (2012), 43 descendants of its own
- K151977: icotec Pedicle System (2016), 30 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K132878: M.U.S.T. Extension (2013), 28 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 EQUATION TM 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-S1) 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/K033495
Methodology: https://510kreport.com/methodology