510(k) · Cleared
ClearedArdis Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 3, 2013 as substantially equivalent to K073202 (Abbott Spine, Inc., 2008) after a 125-day review. Its family tree reaches back 2 generations to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 3, 2013
- Review
- 125 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK073202 Ardis SpacerAbbott Spine, Inc. · 2008 · Recalled (Class I)
- This deviceK131242 Ardis Interbody SystemZimmer Spine, Inc. · 2013
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073202 | Ardis SpacerSummary page 1…lass 11(MAX). Spinal Intervertebral Body Fusion Device, 21 CF7R § 21 CER 888.3080. Predicate Device: Zimmer Spine Ardis®g Spacer System (a.k.a. Ardis Interbody System). K073202 (1/30/08 & Add to File 11/17/11) Device Description:: The Ardis® hiterbody System is a device for interbody fusion of the anteri… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 10 other devices also cite its predicate K073202.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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 lumbasacral region (L2-S 1)in the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ODD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous…
Read the full statement (120 words)
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 lumbasacral region (L2-S 1)in the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ODD 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131242: Ardis Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131242
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026