# K071420: Chameleon Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Jan 16, 2008 after 239 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994308 (2000). 3 ancestors in all.
153 later devices descend from it; 11 cite it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K994308: Nuvasive Townley Facet Screw, Nuvasive, Inc. (2000) Summary page 1.

## Most influential descendants
- K131417: Facet Fixx (2013), 130 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own

## Recalls of this device
- Nov 9, 2012 · Class II · Z-1871-2013: Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical 

## Indications for use
The subject device is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels including: i)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5)Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b)degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.

Source page: https://510kreport.com/device/K071420
Methodology: https://510kreport.com/methodology