# K150570: ANAX OCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Jun 3, 2015 after 89 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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 K953076 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K183383: ANAX™ OCT Spinal System (2018), 1 descendant of its own
- K251725: ANAX™ OCT Spinal System (2025), 0 descendants of its own

## Indications for use
ANAX TM OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAXTM OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, ANAXTM OCT Spinal System may be connected to Perfix TM Spinal System and ANAXTM 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAXTM OCT Spinal System to PerfixTM Spinal System and ANAXTM 5.5 Spinal System.

Source page: https://510kreport.com/device/K150570
Methodology: https://510kreport.com/methodology