510(k) · Cleared
ClearedTM Ardis Interbody System Inserter
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 Mar 1, 2013 as substantially equivalent to K113561 (Zimmer Trabecular Metal Technology, 2012) after a 100-day review. Its family tree reaches back 3 generations to 1996. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 1, 2013
- Review
- 100 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P950002 (1996). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK073202 Ardis SpacerAbbott Spine, Inc. · 2008 · Recalled (Class I)
- 1 generation backK113561 TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012 · Recalled
- This deviceK123602 TM Ardis Interbody System InserterZimmer Trabecular Metal Technology · 2013
- Descendant · cites it directly · 0 of its ownK241073 DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd. · 2024
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K073202 | Ardis Spacer | Abbott Spine, Inc. | 2008 | Class I |
| −1 | K113561 | TM Ardis Interbody System TM Ardis Interbody System Instrumenation | Zimmer Trabecular Metal Technology | 2012 | 2 |
| 0 (this device) | K123602 | TM Ardis Interbody System Inserter | Zimmer Trabecular Metal Technology | 2013 | — |
| +1 | K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationSummary page 2…nc. has submitted documentation demonstrating the substantial equivalence of the modified TM Ardis® Inserter instrument to the original version of the device included in K1 13561. The unmodified and modified versions of the TM Ardise Inserter instrument differ by a design change to th& Inserter Locking Nut… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | 2024 | 0 |
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 · 2 generations back · ◆ 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 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241073 (Shenzhen Dazhou Medical Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K113561.
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 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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123602: TM Ardis Interbody System Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123602
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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