# K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Vertebration,Inc
- Decided: Apr 20, 2007 after 101 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: 3 generations back to K841189 (1984). 9 ancestors in all.
641 later devices descend from it; 2 cite it directly.
1 of 651 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031672: Spinal Concepts, Inc. Infix System, Spinal Concepts, Inc. (2003) Summary page 1.
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 2.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.
- K023835: Devex Mesh System, Depuyacromed (2003) Summary page 1.

## Most influential descendants
- 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
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Indications for use
The XYcorTM Spinal Implant is indicated for use as 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). The XYcorTM Spinal implant 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 XYcorTM Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the XYcorTM Spinal Implant include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.

Source page: https://510kreport.com/device/K070082
Methodology: https://510kreport.com/methodology