# K140948: Romeo Posterior Osteosynthesis System

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: May 20, 2014 after 36 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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.
10 later devices descend from it; 1 cites it directly.
0 of 16 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.
- K101678: Romeo Posterior Osteosynthesis System, Spineart (2010) Summary page 1.

## Most influential descendants
- K172101: ROMEO® 2 Posterior Osteosynthesis System (2017), 9 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own
- K203506: PERLA® TL posterior osteosynthesis system (2021), 3 descendants of its own
- K213470: PERLA® TL Posterior Osteosynthesis System (2022), 2 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-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as a posterior, non-cervical, non-pedicle screw fixation system, Romeo® posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K140948
Methodology: https://510kreport.com/methodology