# K131833: Centurion Poct System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jan 30, 2014 after 224 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: 15 generations back to K003155 (2001). 157 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 1.
- K111183: Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods), Orthofix, Inc. (2011)
- K091689: Synapse System 4.0MM, OC Fusion System 4.0MM, Synthes (Usa) (2009) Summary page 1.
- K122378: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 1.

## Most influential descendants
- K250866: Sovereign Posterior Cervical System (2025), 1 descendant of its own
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); b) spondylolisthesis; c) spinal stenosis; d) trauma (i.e., fracture or dislocation); e) atlanta-axial fracture with instability; f) occipito-cervical dislocation; g) tumors; h) revision of previous cervical spine surgery; The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (TI - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI - T3). The hooks are intended to be placed from CI to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wiretcable attachment to the posterior cervical spine. The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Source page: https://510kreport.com/device/K131833
Methodology: https://510kreport.com/methodology