# K123602: TM Ardis Interbody System Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology
- Decided: Mar 1, 2013 after 100 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 P950002 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 2.

## Most influential descendants
- K241073: DZ-Tabone Intervertebral Body Fusion Device (2024), 0 descendants of its own

## Indications for use
The TM Ardis® Interbody System is indicated for use with autogenous bone graftas an intervertebral body fuision device at one or two contiguous levels in the lumbosacral region (L2-SI1) in the treatment of degenerative disc disease (DOD) 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 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/K123602
Methodology: https://510kreport.com/methodology