# K213470: PERLA® TL Posterior Osteosynthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jan 21, 2022 after 85 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). 519 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 522 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203506: PERLA® TL posterior osteosynthesis system, Spineart (2021) Summary page 4.
- K203222: PERLA TL Posterior Osteosynthesis System, Spineart (2020) Summary page 4.
- K193396: PERLA® TL posterior osteosynthesis system, Spineart (2020) Summary page 4.
- K172101: ROMEO® 2 Posterior Osteosynthesis System, Spineart (2017) Summary page 4.
- K130646: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 4.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 4.

## Most influential descendants
- K253966: PERLA® TL Posterior Thoraco-lumbar Fixation System (2026), 0 descendants of its own
- K230774: PERLA® TL System; TEKTONA® HV US Bone Cement (2023), 0 descendants of its own

## Indications for use
The PERLA® TL 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 PERLA® TL Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL 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/K213470
Methodology: https://510kreport.com/methodology