# K140046: Spinous Process Fusion (SPF) Plate

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity, LLC
- Decided: Jan 9, 2015 after 366 days
- Product code: PEK (Spinous Process Plate)
- 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: 8 generations back to K990745 (1999). 39 ancestors in all.
9 later devices descend from it; 4 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)
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 5.
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 5.
- K130438: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2013) Summary page 5.
- K133091: Zip Mis Interspinous Fusion System, Aurora Spine (2013) Summary page 5.
- K133052: Affix (R) Next Gen Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 5.
- K132411: Affix II Spinous Process Plate System, Nu Vasive, Incorporated (2013) Summary page 5.
- K103205: Bridgepoint  Spinous Process Camp- Posterior Fixation System, Alphatec Spine, Inc. (2011) Summary page 5.
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM), Stryker Spine (2013) Summary page 5.

## Most influential descendants
- 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
- K212781: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (2021), 5 descendants of its own
- K211880: Minuteman G5 MIS Fusion Plate (2022), 4 descendants of its own

## Indications for use
The Spinal Simplicity Spinous Process Fusion (SPF) 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: x degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); x spondylolisthesis; x trauma (i.e., fracture or dislocation); and/or x tumor. The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.

Source page: https://510kreport.com/device/K140046
Methodology: https://510kreport.com/methodology