# K080526: Sierra System

- Pathway: 510(k) (Special)
- Applicant: Seaspine, Inc.
- Decided: Apr 16, 2008 after 50 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 34 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062934: Sierra, Seaspine, Inc. (2006) Summary page 1.
- K022048: Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System, Interpore Cross Intl. (2002) Summary page 1.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.

## Most influential descendants
- K133698: Synapse System (2014), 6 descendants of its own
- K141897: Synapse System, Synthes OC Fusion System (2014), 5 descendants of its own
- K142867: Reliance Posterior Cervical-Thoracic System (2015), 3 descendants of its own
- K213394: Vy Spine™ VySpan™ PCT System (2021), 2 descendants of its own
- K223852: VySpan™ PCT System (2023), 1 descendant of its own

## Indications for use
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows: degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and/or spinal tumor. The occipital bone screws are limited to occipital fixation only. The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K080526
Methodology: https://510kreport.com/methodology