# K231069: PERLA® TL Posterior Thoraco-lumbar Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Oct 25, 2023 after 194 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: 22 generations back to K003155 (2001). 502 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 504 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193396: PERLA® TL posterior osteosynthesis system, Spineart (2020) Summary page 4.
- K203222: PERLA TL Posterior Osteosynthesis System, Spineart (2020) Summary page 4.
- K172101: ROMEO® 2 Posterior Osteosynthesis System, Spineart (2017) Summary page 4.
- K163604: SeaSpine® Daytona® Small Stature Spinal System, SeaSpine Orthopedics Corporation (2017) Summary page 4.
- K180686: SeaSpine Daytona Small Stature Spinal System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K173882: SeaSpine Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2018) Summary page 4.
- K183639: Mariner Outrigger Revision System, SeaSpine Orthopedics Corporation (2019) Summary page 4.

## Most influential descendants
- K253966: PERLA® TL Posterior Thoraco-lumbar Fixation System (2026), 0 descendants of its own

## Indications for use
The PERLA® TL Posterior Thoraco-lumbar Fixation 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 PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation 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/K231069
Methodology: https://510kreport.com/methodology