# K071905: Posterior Cervicothoracic Spinal Fixation System (PCFS)

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, LLC
- Decided: Dec 28, 2007 after 171 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K853033 (1985). 26 ancestors in all.
6 later devices descend from it; 4 cite 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)
- K052317: Modification to:  Stryker Spine Oasys System, Stryker Spine (2005) Summary page 1.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K052180: Modification to Vertex Reconstruction System, Medtronic Sofamor Danek (2005) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004). Our reading of the summary gave K143229, FDA’s number for Nexis osteosynthesis compressive screws (Novastep), decided Feb 6, 2015, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Altius M-INI OCT System”.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1.
- K030197: Blackstone Posterior Cervical System, Blackstone Medical, Inc. (2003) Summary page 1.
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- K092656: Lanx Posterior Cervicothoracic Spinal Fixation System (2009), 5 descendants of its own
- K100888: Modification to Lanx Posterior Cervicothoracic Spinal Fixation System (2010), 3 descendants of its own
- K100191: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) (2010), 3 descendants of its own
- K103040: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) (2011), 2 descendants of its own
- K113434: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) (2011), 1 descendant of its own

## Indications for use
When intended to promote fusion of the cervical spine and the thoracic spine (Cl-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) 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 * Fracture/Dislocation * Failed previous fusion * Tumor 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. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Source page: https://510kreport.com/device/K071905
Methodology: https://510kreport.com/methodology