# K203506: PERLA® TL posterior osteosynthesis system

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jan 15, 2021 after 46 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K003155 (2001). 516 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 520 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.
- K193396: PERLA® TL posterior osteosynthesis system, Spineart (2020) Summary page 4.
- K093936: Romeo Posterior Osteosynthesis System, Spineart (2010) Summary page 4.
- K152457: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K170347: CD HORIZON™ Fenestrated Screw Set, Medtronic Sofamor Danek USA (2017) Summary page 4.

## Most influential descendants
- K213470: PERLA® TL Posterior Osteosynthesis System (2022), 2 descendants of its own
- 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

## Recalls of this device
- Jun 30, 2025 · Class II · Z-2279-2025: Cannulated fenestrated polyaxial screws may be incorrectly labeled
- Jun 30, 2025 · Class II · Z-2280-2025: Cannulated fenestrated polyaxial screws may be incorrectly labeled

## 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/K203506
Methodology: https://510kreport.com/methodology