# K014302: Universal Multiaxis (Unimax) Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Pisharodi Surgicals, Inc.
- Decided: Mar 29, 2002 after 88 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: 1 generation back to K001532 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001532: Dyna-Lok Classic Spinal System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K024313: Modification to Universal Multiaxis (Unimax) Pedicle Screw System (2003), 0 descendants of its own

## Indications for use
The Universal MultiaAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior spinal segments 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: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (8) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis)." When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L.5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (¢} who are having the device fixed or attached to the lumbar and sacral spine (.3 and balow); and (4) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K014302
Methodology: https://510kreport.com/methodology