# K111448: Icon (TM) Modular Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Feb 16, 2012 after 268 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: 6 generations back to K980447 (1998). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042514: Modification to Blackstone Modular Pedicle Screw System, Blackstone Medical, Inc. (2004) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K023498: Modification to Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2002) Summary page 1.
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 1.

## Indications for use
The ICON TM Modular Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedlicle fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft bone. The device is indicated for all of the following indications: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation), 4. Spinal stenosis 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor, 7. Pseudoarthrosis, and 8. Failed previous fusion The ICON TM Modular Spinal Fixation System components may be used with certain components of the Orthofix SF5 system, including rods, rod connectors and cross-connectors.

Source page: https://510kreport.com/device/K111448
Methodology: https://510kreport.com/methodology