# K133184: Ardis Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Jan 30, 2014 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: 2 generations back to P950002 (1996). 2 ancestors in all.
20 later devices descend from it; 1 cites it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 1.

## 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
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own

## Indications for use
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 I 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.

Source page: https://510kreport.com/device/K133184
Methodology: https://510kreport.com/methodology