# K062670: Vertiflex Spinal Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Vertiflex (Tm), Incorporated
- Decided: Jan 12, 2007 after 127 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: 8 generations back to K901587 (1990). 54 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043232: Ucr Spinal System, Seaspine (2004) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 1.
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.
- K041925: ST360 Spinal Fixation System, Zimmer Spine, Inc. (2004) Summary page 1.
- K043343: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K030625: Spinal Concepts Inc. Pathfinder, Spinal Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K073245: Extended Vertiflex Spinal Screw System (2008), 10 descendants of its own
- K102870: Exactech Proliant Polyaxial Pedicle Screw System (2011), 9 descendants of its own
- K151704: Diplomat® Spinal System (2016), 4 descendants of its own
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own

## Indications for use
When used as a posterior, noncervical pedicle screw system, the VertiFlexTM Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; * Severe spondylolisthesis (Grades 3 and 4) of the L5-SI vertebra; * Degenerative spondylolisthesis; * Trauma (i.e., fracture or dislocation); * Spinal stenosis; * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * Tumor; * Pseudoarthrosis; and/or * Failed previous fusion.

Source page: https://510kreport.com/device/K062670
Methodology: https://510kreport.com/methodology