# K200571: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: May 1, 2020 after 58 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: 16 generations back to K003155 (2001). 128 ancestors in all.
No later device cites it as a predicate yet.
1 of 129 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011) Summary page 4.
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 4.
- K161032: neon3™  universal OCT spinal stabilization, Ulrich GmbH & Co. KG (2016) Summary page 4.
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K132504: Tiger Occipital-Cervical-Thoracic Spinal Fixation System, Corelink, LLC (2013) Summary page 4.
- K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System, Pioneer Surgical Technology, Inc. (2012) Summary page 4.
- K111719: Oasys Spinal System, Stryker Spine (2012) Summary page 4.

## Indications for use
The PERLA® posterior occipito-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 crania-cervical junction, the cervical spine (Cl to C7) and the thoracic spine (T to 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 occipito-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. The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (CI to C7) and the thoracic spine (T1 to T3). In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods may also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.

Source page: https://510kreport.com/device/K200571
Methodology: https://510kreport.com/methodology