# K082466: Xycor Spinal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Vertebration,Inc
- Decided: Jan 9, 2009 after 135 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: 4 generations back to K841189 (1984). 10 ancestors in all.
42 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery, Vertebration,Inc (2007) Summary page 1.

## Most influential descendants
- K160646: XYcor® Expandable Spinal Spacer System (2016), 41 descendants of its own
- K202587: ATEC Lateral Interbody System (2020), 39 descendants of its own
- K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (2021), 38 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 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 for vertebral body replacement. 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. The XYcorTm Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e.; facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).

Source page: https://510kreport.com/device/K082466
Methodology: https://510kreport.com/methodology