# K123767: Lanx Fusion System- SA

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Mar 18, 2013 after 101 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 21 ancestors in all.
324 later devices descend from it; 7 cite it directly.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102738: Lanx Fusion System, Lanx, LLC (2011) Summary page 1.

## Most influential descendants
- K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System (2013), 269 descendants of its own
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System (2014), 265 descendants of its own
- K142095: Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System (2014), 254 descendants of its own
- K143126: Renovis S141 Lumbar Interbody Cage System (2015), 237 descendants of its own
- K151374: NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (2015), 235 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0400-2014: Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the D
- Aug 22, 2013 · Class II · Z-0978-2015: The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into
- Aug 22, 2013 · Class II · Z-0982-2015: The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
- Aug 22, 2013 · Class II · Z-0983-2015: The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into

## 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 raft in skeletally mature patients with degenerative disc disease ("DDD ") 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 JLanx 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 raft in skeletally mature patients with degenerative disc disease ("DDD ') at one or two contiguous spinal levels from L2-SJ. DDD 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 DDD patients may have had a previous non-fusion spinal surgery at the involved, spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation. 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 LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. TI- LS) for partial replacement (h~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 biomechanical 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/K123767
Methodology: https://510kreport.com/methodology