# K153386: Perla Posterior Cervico-Thoracic Fixation system

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jan 25, 2016 after 63 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953076 (1997). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K190071: Perla® Posterior Cervico-Thoracic Fixation System (2019), 1 descendant of its own
- K222107: Black Diamond™ POCT Spinal System (2022), 0 descendants of its own

## Indications for use
The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

Source page: https://510kreport.com/device/K153386
Methodology: https://510kreport.com/methodology