# K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Dec 15, 2000 after 105 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: 3 generations back to K853033 (1985). 8 ancestors in all.
671 later devices descend from it; 16 cite it directly.
2 of 680 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965221: Ransford Cervical Fixation System, Surgicraft, Ltd. (1997) Summary page 1.
- K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System, Synthes (Usa) (1998) Summary page 1.
- K984377: Synthes Spine Cervifix System, Synthes (Usa) (1999) Summary page 1.
- K990965: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 1.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 1.
- K994187: Synthes Cervifix System, Synthes (Usa) (1999) Summary page 1.
- K001864: Synthes Cervifix System, Synthes Spine (2000) Summary page 1.

## Most influential descendants
- K013222: Summit Occipito-Cervico- Thoracic (Oct) Spinal System (2001), 660 descendants of its own
- 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

## 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 4n the tipper theracic spine (Tl-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, Syst-'M allows1or wire/cable attachment to the posterior cervical spine.

Source page: https://510kreport.com/device/K002733
Methodology: https://510kreport.com/methodology