# K103660: Lanx Cervical Intervertebral Body Fusion System

- Pathway: 510(k) (Special)
- Applicant: Lanx, Inc.
- Decided: Feb 28, 2011 after 75 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K841189 (1984). 35 ancestors in all.
41 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083815: Lanx Fusion System, Lanx, Inc. (2009) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System (2015), 17 descendants of its own
- K171075: Calix-C Cervical Interbody Spacer (2017), 15 descendants of its own
- K130948: C-Fuse Cervical Intervertebral Body Fusion System (2013), 13 descendants of its own
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("ODD") at one spinal level from the C2-C3 disc to the C7-TI disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System. When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("IDDD") at one or two contiguous spinal levels from L2-S1. ODD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DOD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System. When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., TI- L5) for partial replacement (i.e., partial vertebrectomy) of 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 Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomnechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K103660
Methodology: https://510kreport.com/methodology