# K073278: Spinous Process Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Mar 28, 2008 after 128 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
No predicates in its family tree.
58 later devices descend from it; 17 cite it directly.
0 of 59 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 no predicate by number.

## Most influential descendants
- K102195: SP-Fix Spinous Process Fixation Plate (2011), 32 descendants of its own
- K131238: Affix Spinous Process Plate System (2013), 30 descendants of its own
- K132411: Affix II Spinous Process Plate System (2013), 20 descendants of its own
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), 18 descendants of its own
- K122509: Vertiflex Spinous Process Fixation Plate (2012), 18 descendants of its own

## Indications for use
The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti - SI). It is intended for plate fixation/attachment to spinous process 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. It is not intended for stand-alone use.

Source page: https://510kreport.com/device/K073278
Methodology: https://510kreport.com/methodology