# K073202: Ardis Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Spine, Inc.
- Decided: Jan 30, 2008 after 78 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P950002 (1996). 1 ancestor in all.
644 later devices descend from it; 11 cite it directly.
1 of 646 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.

## Most influential descendants
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation (2012), 476 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K103111: Forza Spacer System (2011), 343 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

## Recalls of this device
- Nov 12, 2012 · Class I · Z-0594-2013: Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks dur

## Indications for use
The ArdisTM Spacer 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 ArdisTM Spacer 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/K073202
Methodology: https://510kreport.com/methodology