# K022048: Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Dec 4, 2002 after 163 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
No predicates in its family tree.
181 later devices descend from it; 5 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Summit Occipito-Cervico-Thoracic (OCT) Spinal System: named in the summary without a submission number

## Most influential descendants
- K052402: Vertex Reconstruction System (2005), 180 descendants of its own
- K052734: Modification to: Vertex Reconstruction System (2005), 175 descendants of its own
- K062879: Traverse Oct Spinal Fixation System (2006), 151 descendants of its own
- K070742: Modification to Vertex Reconstruction System (2007), 150 descendants of its own
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System (2009), 138 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International (ICI) Occipito-Cervico-Thoracic (OCT) Rod and Plate 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 Atlantoaxial fracture with instability Occipitocervical dislocation Revision of previous cervical spine surgery Tumors The occipital bone screws are limited to occipital fixation only.

Source page: https://510kreport.com/device/K022048
Methodology: https://510kreport.com/methodology