# K041203: Summit Oct Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Jun 2, 2004 after 26 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: 7 generations back to K853033 (1985). 13 ancestors in all.
657 later devices descend from it; 12 cite it directly.
2 of 671 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.

## Most influential descendants
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own
- K063156: Modification to Expedium Spine System (2006), 424 descendants of its own
- K063741: Expedium Spine System (2007), 398 descendants of its own
- K080313: Modification to Expedium Spine System (2008), 397 descendants of its own
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System (2004), 301 descendants of its own

## Indications for use
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows: When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for: * ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * spondylolisthesis * spinal stenosis * fracture/dislocation * atlanto/axial fracture with instability * occipitocervical dislocation * revision of previous cervical spine surgery * tumors The occipital bone screws are limited to occipital fixation only. The use of the minipolyaxial 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. The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine. The Summit OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Source page: https://510kreport.com/device/K041203
Methodology: https://510kreport.com/methodology