# K113434: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)

- Pathway: 510(k) (Special)
- Applicant: Lanx, Inc.
- Decided: Dec 19, 2011 after 28 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: 13 generations back to K853033 (1985). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103040: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS), Lanx, LLC (2011) Summary page 1.
- K100888: Modification to Lanx Posterior Cervicothoracic Spinal Fixation System, Lanx, Inc. (2010) Summary page 1.
- K100191: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS), Lanx, Inc. (2010) Summary page 1.
- K092656: Lanx Posterior Cervicothoracic Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K071905: Posterior Cervicothoracic Spinal Fixation System (PCFS), Lanx, LLC (2007) Summary page 1.

## Most influential descendants
- K140734: Nextgen Altius Oct System (2014), 0 descendants of its own

## Indications for use
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3)) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following: * Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Trauma/Fracture/Dislocation * Atlanto-Axial Fracture with Instability * Occipito-Cervical Dislocation * Failed Previous Fusion * Tumor The use of occipital bone screws is limited to placement in the occiput only. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K113434
Methodology: https://510kreport.com/methodology