# K122509: Vertiflex Spinous Process Fixation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Vertiflex, Inc.
- Decided: Dec 17, 2012 after 122 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990745 (1999). 30 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.
- K100935: Lanx Spinal Fixation System, Lanx, Inc. (2010) Summary page 1.
- K101471: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2010) Summary page 1.
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010) Summary page 1.
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 1.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.
- K043053: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.
- DEN110002: System 1E Process Biological Monitoring Kit, STERIS Corporation (2012). Our reading of the summary gave K102866, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110002, System 1E Process Biological Monitoring Kit (STERIS Corporation), granted Mar 30, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM) (2013), 12 descendants of its own
- K140046: Spinous Process Fusion (SPF) Plate (2015), 9 descendants of its own
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), 8 descendants of its own
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), 7 descendants of its own
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), 6 descendants of its own

## Indications for use
The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K122509
Methodology: https://510kreport.com/methodology