# K121979: Pass Oct Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Mar 21, 2013 after 258 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: 9 generations back to K853033 (1985). 36 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 51 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 3.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 3.
- K062136: Pass 2 Spinal System, Medicrea (2006) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K052734: Modification to: Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 3.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 3.

## Most influential descendants
- K150918: PASS OCT Spinal System (2015), 13 descendants of its own
- K173522: Solanas® Posterior Stabilization System (2017), 5 descendants of its own
- K191185: Solanas® Posterior OCT Fixation System (2019), 4 descendants of its own
- K153169: PASS OCT Patient Specific Rods (2016), 4 descendants of its own
- K210449: Infinity™ OCT System, PASS OCT® Spinal System (2021), 3 descendants of its own

## Indications for use
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for: -Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. - Spondylolisthesis - Spinal Stenosis - Trauma (i.e. Fracture or Dislocation) - Atlanto/axial fracture with instability - Revision of previous cervical spine surgery - Tumors Occipital Plates!/ Occipital Bone Screws / Hooks: The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only. The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs. Hooks and rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Polvaxial screws/Connectors: The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine. The PASS OCT Spinal System can also be linked to the PASS LP9 Spinal System using the dual diameter rod.

Source page: https://510kreport.com/device/K121979
Methodology: https://510kreport.com/methodology