# K111127: Romeo Posterior Osteosynthesis System

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: Aug 11, 2011 after 112 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 4 generations back to K011437 (2001). 5 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081165: Ellipse Lumbar Posterior Osteosynthesis System, Spineart (2008) Summary page 1.
- K093170: Romeo Posterior Osteosynthesis System, Spineart (2009) Summary page 1.
- K101678: Romeo Posterior Osteosynthesis System, Spineart (2010) Summary page 1.

## Most influential descendants
- K130267: Romeo Posterior Osteosynthesis System (2013), 12 descendants of its own
- K141835: Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods (2014), 11 descendants of its own
- K151695: Romeo posterior osteosynthesis system (2015), 10 descendants of its own
- K172101: ROMEO® 2 Posterior Osteosynthesis System (2017), 9 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own

## Indications for use
ROMEO posterior osteosynthesis 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 or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-Si vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K111127
Methodology: https://510kreport.com/methodology