# K172101: ROMEO® 2 Posterior Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Sep 26, 2017 after 76 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 18 generations back to K003155 (2001). 389 ancestors in all.
9 later devices descend from it; 5 cite it directly.
1 of 399 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081165: Ellipse Lumbar Posterior Osteosynthesis System, Spineart (2008) Summary page 4.
- K093170: Romeo Posterior Osteosynthesis System, Spineart (2009) Summary page 4.
- K093936: Romeo Posterior Osteosynthesis System, Spineart (2010) Summary page 4.
- K101678: Romeo Posterior Osteosynthesis System, Spineart (2010) Summary page 4.
- K111127: Romeo Posterior Osteosynthesis System, Spineart (2011) Summary page 4.
- K112108: Romeo Posterior Osteosynthesis System, Spineart (2011) Summary page 4.
- K130267: Romeo Posterior Osteosynthesis System, Spineart (2013) Summary page 4.
- K140948: Romeo Posterior Osteosynthesis System, Spineart (2014) Summary page 4.
- K151695: Romeo posterior osteosynthesis system, Spineart (2015) Summary page 4.
- K143248: Reform Pedicle Screw System, Precision Spine, Inc. (2014) Summary page 4.
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 4.
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal, Stryker Spine (2013) Summary page 4.

## Most influential descendants
- 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
- K231069: PERLA® TL Posterior Thoraco-lumbar Fixation System (2023), 1 descendant of its own

## Indications for use
The ROMEO® 2 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K172101
Methodology: https://510kreport.com/methodology