# K022143: Interpore Cross International Anterior Fixation Device (Afd)

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Jan 23, 2003 after 205 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
No predicates in its family tree.
968 later devices descend from it; 3 cite it directly.
1 of 969 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GEO Structure: named in the summary without a submission number

## Most influential descendants
- K031672: Spinal Concepts, Inc. Infix System (2003), 862 descendants of its own
- K081501: Solitaire Anterior Spinal System (2008), 834 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery (2007), 641 descendants of its own

## Indications for use
The Interpore Cross International AFD is indicated for use in the thoracolumbar spine @e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Interpore Cross International AFD is also indicated for treating fractures of the thoracic and lumbar spine. The Interpore Cross International AFD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fhion for a prolonged period.

Source page: https://510kreport.com/device/K022143
Methodology: https://510kreport.com/methodology