510(k) · Cleared
ClearedTM-400 Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular Metal Technology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 15, 2012 as substantially equivalent to K052950 (Zimmer Trabecular, 2005) and 6 other predicates after a 144-day review. Its family tree reaches back 7 generations to 2001. 1 of the 47 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 144 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K003709 (2001). 26 ancestors in all, the oldest P950002 (1996). 20 later devices descend from it, 1 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK003709 Surgical Dynamics Mesh Cage SystemUnited States Surgical, A Division of Tyco Healthc · 2001
- 6 generations backK021025 Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZImplex Corp. · 2002
- 5 generations backK021967 Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and…Implex Corp. · 2002
- 4 generations backK022563 Hydrocel Vertebral Body Replacement, Model 06-172-00XX1Implex Corp. · 2002
- 3 generations backK051196 Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and…Implex Corp. · 2005
- 2 generations backK051978 Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
- 1 generation backK052950 The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005
- This deviceK120203 TM-400 DeviceZimmer Trabecular Metal Technology, Inc. · 2012
- 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 |
|---|---|---|---|---|---|
| −7 | K003709 | Surgical Dynamics Mesh Cage System | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −6 | K021025 | Modification to Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ | Implex Corp. | 2002 | — |
| −5 | K021967 | Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2 | Implex Corp. | 2002 | — |
| −4 | K022563 | Hydrocel Vertebral Body Replacement, Model 06-172-00XX1 | Implex Corp. | 2002 | — |
| −3 | K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1 | Implex Corp. | 2005 | — |
| −2 | K051978 | Trabecular Metal Vertebral Body Replacement | Implex Corp. | 2005 | — |
| −1 | K052950 | The Zimmer TMT Trabecular Metal Vertebral Body Replacement System | Zimmer Trabecular | 2005 | — |
| 0 (this device) | K120203 | TM-400 Device | Zimmer Trabecular Metal Technology, Inc. | 2012 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 1 |
| 2010 | 1 | 0 |
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? (7)
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 |
|---|---|---|---|
| * | K052950 | The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemSummary page 2…Device(s): The TM-400 Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202… | 2005 |
| * | K031823 | Hedrocel Vertebral Body Replacement, Model 06-172-00XX1Summary page 2…): The TM-400 Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biom… | 2003 |
| * | K010378 | Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZSummary page 2…-400 Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biomet Enclave… | 2002 |
| * | K093127 | Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetSummary page 2…ly equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biomet Enclave cleared under KO081636 and the Orthofi… | 2010 |
| * | K073202 | Ardis SpacerSummary page 2…es include this TM-400 Device as a VBR (K052950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biomet Enclave cleared under KO081636 and the Orthofix Pillar AL cleared under K082235. The TM-400 Device has the identical… | 2008 |
| * | K081636 | Peek-Optima Alif SpacerSummary page 2…950, K03 1823, K01 0378 and, for the instrumentation, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biomet Enclave cleared under KO081636 and the Orthofix Pillar AL cleared under K082235. The TM-400 Device has the identical material as previously cleared devices. Th… | 2008 |
| * | K082235 | Blackstone Pillar XL Peek SpacersSummary page 2…tion, K093 127), the Zimmer Spine, Inc. Ardis* Interbody System cleared under K073202, the Biomet Enclave cleared under KO081636 and the Orthofix Pillar AL cleared under K082235. The TM-400 Device has the identical material as previously cleared devices. Theintenided use and indications for use of the sub… | 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 · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3 months on median.
- 3 of the 26 ancestors have 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.
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-400 device is a Vertebral Body Replacement device intended for use in the thoracolumbar spine (TI - L-5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft. The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with…
Read the full statement (148 words)
The TM-400 device is a Vertebral Body Replacement device intended for use in the thoracolumbar spine (TI - L-5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.
The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120203 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120203: TM-400 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120203
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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