# K193396: PERLA® TL posterior osteosynthesis system

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Feb 5, 2020 after 61 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: 20 generations back to K003155 (2001). 500 ancestors in all.
7 later devices descend from it; 6 cite it directly.
1 of 508 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172101: ROMEO® 2 Posterior Osteosynthesis System, Spineart (2017) Summary page 4.
- K183639: Mariner Outrigger Revision System, SeaSpine Orthopedics Corporation (2019) Summary page 4.
- K173130: Reform® Midline Cortical Screw System, Precision Spine, Inc. (2017) Summary page 4.
- K151422: Reform Pedicle Screw System, Precision Spine, Inc. (2015) Summary page 4.

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

## Recalls of this device
- Mar 15, 2024 · Class II · Z-1758-2024: Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tighten
- Apr 9, 2021 · Class II · Z-1975-2021: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

## 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/K193396
Methodology: https://510kreport.com/methodology