# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Feb 12, 2015 after 87 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: 10 generations back to K010530 (2001). 52 ancestors in all.
19 later devices descend from it; 3 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132790: Infix Anterior Lumbar System, Zimmer Spine, Inc. (2013) Summary page 9.
- K133184: Ardis Interbody System, Zimmer Spine, Inc. (2014) Summary page 9.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 9.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 9.
- K031672: Spinal Concepts, Inc. Infix System, Spinal Concepts, Inc. (2003) Summary page 9.
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 9.
- K070754: Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155, Zimmer Trabecular Metal Technology (2007) Summary page 9.
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 9.
- K133784: Vista-S Device, Associated Instrumentation, Zimmer Trabecular Metal Technology (2014) Summary page 9.
- K111983: Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 9.
- K120203: TM-400 Device, Zimmer Trabecular Metal Technology, Inc. (2012) Summary page 9.

## Most influential descendants
- 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
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (2021), 3 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.c., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix System 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 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 (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD 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. The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD 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. The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. The BAK device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels(s). BAK devices are to be implanted via an open anterior or posterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach. All BAK devices are also indicated for laparoscopic implantation at the L4-L5 and L5-S1 levels for the same clinical indications described above. Cadence and TraXis are vertebral body replacement devices that are 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). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Source page: https://510kreport.com/device/K143297
Methodology: https://510kreport.com/methodology