# K062254: Axis Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 16, 2008 after 682 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K953076 (1997). 2 ancestors in all.
222 later devices descend from it; 2 cite it directly.
1 of 225 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953076: Townley Facet/Pedicular Screw Plating System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K021705: Modification to Townley Transfacepedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Most influential descendants
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System (2015), 192 descendants of its own
- K143471: VERTEX Reconstruction System (2015), 165 descendants of its own
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), 96 descendants of its own
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), 78 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own

## Indications for use
The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. The AXIS® Fixation System must be used with autograft or allograft.

Source page: https://510kreport.com/device/K062254
Methodology: https://510kreport.com/methodology