# K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Nov 7, 2001 after 41 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: 4 generations back to K853033 (1985). 10 ancestors in all.
660 later devices descend from it; 8 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.
- K001864: Synthes Cervifix System, Synthes Spine (2000)

## Most influential descendants
- K022190: Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System (2002), 659 descendants of its own
- K030103: Summit Oct Spinal System Minipolyaxial Screws (2003), 658 descendants of its own
- K041203: Summit Oct Spinal System (2004), 657 descendants of its own
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own
- K063156: Modification to Expedium Spine System (2006), 424 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated 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 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/K013222
Methodology: https://510kreport.com/methodology