510(k) · Cleared
Recalled · Class II · 2016TM Ardis Interbody System TM Ardis Interbody System Instrumenation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular Metal Technology · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 29, 2012 as substantially equivalent to K073202 (Abbott Spine, Inc., 2008) and 2 other predicates after a 180-day review. Its family tree reaches back 2 generations to 1996. 1 of the 485 devices in its family, counting itself, has a Class I recall. 476 later devices descend from it. It has been recalled 2 times.
- Decided
- May 29, 2012
- Review
- 180 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to P950002 (1996). 8 ancestors in all. 476 later devices descend from it, 6 citing it directly. 1 of the 485 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 deviceK113561 TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012
- Descendant · cites it directly · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
Showing 5 of 476 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 476 · See all- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · cites it directly459descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on227descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 2 generations on169descendants
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) | K113561 | TM Ardis Interbody System TM Ardis Interbody System Instrumenation | Zimmer Trabecular Metal Technology | 2012 | — |
| +1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 0 |
| 2017 | 21 | 0 |
| 2018 | 24 | 0 |
| 2019 | 32 | 0 |
| 2020 | 48 | 0 |
| 2021 | 45 | 0 |
| 2022 | 51 | 0 |
| 2023 | 68 | 0 |
| 2024 | 74 | 0 |
| 2025 | 55 | 0 |
| 2026 | 49 | 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? (3)
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 2…is®O Interbody System by Zimmer Spine Ki'3s1h (K073202), Lucent Lumbar Interbody System by Spinal Elements (K07 1724), TM-S Fusion Device by Zimmer Trabecular Metal Technology (KI 0303… | 2008 |
| * | K071724 | LucentSummary page 2…Ki'3s1h (K073202), Lucent Lumbar Interbody System by Spinal Elements (K07 1724), TM-S Fusion Device by Zimmer Trabecular Metal Technology (KI 03033). The TM Ardis® Interbody System has the identical material… | 2007 |
| * | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx | 2011 |
What descends from it? (476)
See all 4766 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150481 | Cascadia Interbody System | 2015 | 459 |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody… | 2015 | 19 |
| K123602 | TM Ardis Interbody System Inserter | 2013 | 1 |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | 2022 | 0 |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | 2021 | 0 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2016 | Class III | Z-1892-2017 | Unknown/Undetermined by firm | 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 to distributors and sales… |
| Sep 20, 2012 | Class II | Z-0659-2013 | Device Design | 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 reports where the inserter instrument… |
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 16 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 8 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K150481 (K2m, Inc., 2015) has gone furthest, with 459 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. 2012, 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 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…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113561
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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