# K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology
- Decided: May 29, 2012 after 180 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P950002 (1996). 8 ancestors in all.
476 later devices descend from it; 6 cite it directly.
1 of 485 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 2.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 2.
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011)

## Most influential descendants
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own

## Recalls of this device
- Jul 7, 2016 · Class III · Z-1892-2017: This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated t
- Sep 20, 2012 · Class II · Z-0659-2013: Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two 

## Indications for use
The TM 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-Si1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DODD 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 TM Ardis® interbody System device 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/K113561
Methodology: https://510kreport.com/methodology