# K073144: Lanx Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, LLC
- Decided: Jan 24, 2008 after 78 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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
No predicates in its family tree.
463 later devices descend from it; 5 cite it directly.
0 of 464 devices in its family (counting itself) have 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) Zimmer Spine, Inc. BAK Vista Interbody Fusion System: named in the summary without a submission number
- (no number) DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System: named in the summary without a submission number
- (no number) Lanx, LLC, Lanx Vertebral Body Replacement Device: named in the summary without a submission number

## Most influential descendants
- K083815: Lanx Fusion System (2009), 451 descendants of its own
- K102738: Lanx Fusion System (2011), 328 descendants of its own
- K123767: Lanx Fusion System- SA (2013), 324 descendants of its own
- 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

## Indications for use
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. 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 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 supplimental fixation systems include the Lanx Spinal Fixation System.

Source page: https://510kreport.com/device/K073144
Methodology: https://510kreport.com/methodology