# K031672: Spinal Concepts, Inc. Infix System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Aug 7, 2003 after 69 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- 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: 2 generations back to K010530 (2001). 3 ancestors in all.
862 later devices descend from it; 6 cite it directly.
1 of 866 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.
- K020048: Modification to Geo Structure, Interpore Cross Intl. (2002) Summary page 1.
- K022143: Interpore Cross International Anterior Fixation Device (Afd), Interpore Cross Intl. (2003)

## Most influential descendants
- K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery (2007), 641 descendants of its own
- K090566: Pathway Avid (2009), 639 descendants of its own
- K112359: Prow Fusion (2011), 601 descendants of its own
- K130820: Expandable Lumbar Interbody System (2013), 593 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own

## Indications for use
The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix is intended to be used with bone graft.

Source page: https://510kreport.com/device/K031672
Methodology: https://510kreport.com/methodology