# K132790: Infix Anterior Lumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Dec 20, 2013 after 105 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
Longest line of descent: 3 generations back to K010530 (2001). 6 ancestors in all.
28 later devices descend from it; 5 cite it directly.
1 of 35 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 2.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 2.

## Most influential descendants
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (2015), 19 descendants of its own
- K162986: SPIRA Open Matrix ALIF (2017), 11 descendants of its own
- K180724: SPIRA Open Matrix LLIF (2018), 10 descendants of its own
- K190483: SPIRA Open Matrix ALIF and LLIF (2019), 9 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
When used as a vertebral body replacement device, the InFix® System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e.. partial verlebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix is designed to restore the biomnechanical integrity of the anterior and middle spinal column even in the absence of fusion for a prolonged period. the InFix implant is intended to be used with bone graft. When used as an intervertebral body fusion device the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (ODD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DOD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation. For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

Source page: https://510kreport.com/device/K132790
Methodology: https://510kreport.com/methodology