# K072729: Sierra

- Pathway: 510(k) (Special)
- Applicant: Seaspine, Inc.
- Decided: Apr 17, 2008 after 204 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.
5 later devices descend from it; 1 cites it directly.
0 of 40 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
- K112025: Sure Lok Mini Posterior Cervical/Upper Thoracic System (2011), 4 descendants of its own
- K150851: Sure Lok Mini Posterior Cervical/Upper Thoracic System (2015), 3 descendants of its own
- K162300: Reform® POCT System (2016), 2 descendants of its own
- K172495: Reform® POCT System (2018), 1 descendant of its own
- K222107: Black Diamond™ POCT Spinal System (2022), 0 descendants 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/K072729
Methodology: https://510kreport.com/methodology