# K141508: Romeo 2 Pad Posterior Axial Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Aug 21, 2014 after 76 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: 7 generations back to K990745 (1999). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 4.
- K112592: Axle Peek Interspinous Fusion System, X-Spine Systems, Inc. (2011) Summary page 4.
- K130438: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 4.
- K092536: Spinal Fixation System, Lanx, Inc. (2009) Summary page 4.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 4.
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 4.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 4.

## Most influential descendants
- K161016: Z-Clamp ISP System (2016), 0 descendants of its own

## Indications for use
The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L.1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with 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 ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.

Source page: https://510kreport.com/device/K141508
Methodology: https://510kreport.com/methodology