# K062934: Sierra

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Nov 16, 2006 after 49 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K853033 (1985). 33 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 1.
- K010681: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 1.
- K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 1.
- K022190: Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2002) Summary page 1.
- K030103: Summit Oct Spinal System Minipolyaxial Screws, Depuyacromed (2003) Summary page 1.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) 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.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K022015: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K023555: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K042402: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2004) Summary page 1.
- K042498: Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 1.
- K042524: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2004) Summary page 1.
- K052180: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.
- K052376: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.
- K052734: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.
- K053483: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2006) Summary page 1.

## Most influential descendants
- K080526: Sierra System (2008), 9 descendants of its own
- K133698: Synapse System (2014), 6 descendants of its own
- K141897: Synapse System, Synthes OC Fusion System (2014), 5 descendants of its own
- K072729: Sierra (2008), 5 descendants of its own
- K112025: Sure Lok Mini Posterior Cervical/Upper Thoracic System (2011), 4 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/K062934
Methodology: https://510kreport.com/methodology