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 Jan 30, 2014 as substantially equivalent to K073202 (Abbott Spine, Inc., 2008) after a 105-day review. Its family tree reaches back 2 generations to 1996. 1 of the 23 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Jan 30, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). 20 later devices descend from it, 1 citing it directly. 1 of the 23 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 deviceK133184 Ardis Interbody SystemZimmer Spine, Inc. · 2014
- Descendant · cites it directly · 19 of its ownK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- Descendant · 2 generations on · 11 of its ownK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- Descendant · 3 generations on · 10 of its ownK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
- Descendant · 3 generations on · 9 of its ownK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
- Descendant · 2 generations on · 5 of its ownK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
Most influential descendants
Showing 5 of 20 · See all- K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc. · 2015 · cites it directly19descendants
- K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017 · 2 generations on11descendants
- K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018 · 3 generations on10descendants
- K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019 · 3 generations on9descendants
- K172424Velofix™ SA Cervical CageU&I Corporation · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K073202 | Ardis Spacer | Abbott Spine, Inc. | 2008 | Class I |
| 0 (this device) | K133184 | Ardis Interbody System | Zimmer Spine, Inc. | 2014 | — |
| +1 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical… | Zimmer Spine, Inc. | 2015 | — |
| +2 | K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 | — |
| +3 | K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | 2018 | — |
| +3 | K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 | — |
| +2 | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
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…R § 888.3080 Regulation Description: Intervertebral Body Fusion Device Predicate Device: Ardis Spacer (K073202) General Device Description: The Ardis@ Interbody System is an implant device for interbody fusion of the anterior column of the… | 2008 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody… | 2015 | 19 |
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 18 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.
- Of its descendants, K143297 (Zimmer Spine, Inc., 2015) has gone furthest, with 19 descendants of its own.
- 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. 2014, 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 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…
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133184: Ardis Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133184
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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