# K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Oct 7, 2004 after 22 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: 8 generations back to K853033 (1985). 14 ancestors in all.
301 later devices descend from it; 21 cite it directly.
1 of 316 devices in its family (counting itself) has 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.
- K984377: Synthes Spine Cervifix System, Synthes (Usa) (1999) Summary page 1.

## Most influential descendants
- K080828: Mountaineer Oct Spinal System (2008), 242 descendants of its own
- K103100: Mountaineer Oct Spinal System (2010), 184 descendants of its own
- K110353: Mountaineer Oct Spinal System (2011), 156 descendants of its own
- K073654: Blackstone Ascent Poct System Parallel Rod Connector (2008), 129 descendants of its own
- K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System (2008), 124 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-Cervical-Thoracic (OCT) Spinal System and the Mountaineer 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 and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine. The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH, MOSS MIAMI, and EXPEDIUM Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Source page: https://510kreport.com/device/K042508
Methodology: https://510kreport.com/methodology