# K081883: Modification to Preference Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Us Spine
- Decided: Sep 24, 2008 after 84 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: 7 generations back to K992147 (2000). 43 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081296: Preference Pedicle Screw System, Us Spine (2008) Summary page 2.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 2.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 2.
- K080928: Xia Spinal System, Stainless Steel Uni-Planar Screws, Stryker Spine (2008) Summary page 2.
- K060361: Xia Spinal System, Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 2.

## Most influential descendants
- K162160: Preference Elite Pedicle Screw System (2016), 1 descendant of its own
- K212185: Golden Isles Pedicle Screw System (2021), 0 descendants of its own

## Indications for use
The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle 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) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis) and/or spinal deformities such as scoliosis, kyphosis or excessive lordosis. In addition, when used as a pedicle screw fixation system, the Preference Pedicle 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. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

Source page: https://510kreport.com/device/K081883
Methodology: https://510kreport.com/methodology