# K021009: Octafix Occipital Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Jun 18, 2002 after 82 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: 1 generation back to K011969 (2001). 1 ancestor in all.
184 later devices descend from it; 3 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011969: Synthes Cervifix System, Synthes (Usa) (2001)

## 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
The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervim-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), sp@ylolisthe.sis, spinal stenosis, hcture/dislocation, adanto-axial fracture with instabhy, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors. The UBP I1 Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the Oafiix Occipital Cervical Plating System to allow for occipital fixation. These UBP 11Bone Screws are limited to occipital fixation only. The C-Fixm Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine. The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine vl-T3) for additional stab the indications specified above.

Source page: https://510kreport.com/device/K021009
Methodology: https://510kreport.com/methodology