# K123623: Illico Mis Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Feb 14, 2013 after 83 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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: 8 generations back to K040583 (2004). 70 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033090: Icon Polyaxial Pedicle Screw System, Alphatec Mfg., Inc. (2004) Summary page 2.
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 2.
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2007) Summary page 2.
- K091189: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2009) Summary page 2.
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 2.

## Most influential descendants
- K181980: OsseoScrew System (2018), 1 descendant of its own
- K202327: Invictus™ OsseoScrew® System (2020), 0 descendants of its own

## Recalls of this device
- Jun 28, 2013 · Class II · Z-2086-2013: The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a p

## Indications for use
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin wit degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.

Source page: https://510kreport.com/device/K123623
Methodology: https://510kreport.com/methodology