# K120203: TM-400 Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology, Inc.
- Decided: Jun 15, 2012 after 144 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003709 (2001). 26 ancestors in all.
20 later devices descend from it; 1 cites it directly.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052950: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System, Zimmer Trabecular (2005) Summary page 2.
- K031823: Hedrocel Vertebral Body Replacement, Model 06-172-00XX1, Implex Corp. (2003) Summary page 2.
- K010378: Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ, Implex Corp. (2002) Summary page 2.
- K093127: Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument Set, Zimmer Trabecular Metal Technology (2010) Summary page 2.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 2.
- K081636: Peek-Optima Alif Spacer, Biomet Spine (2008) Summary page 2.
- K082235: Blackstone Pillar XL Peek Spacers, Blackstone Medical, Inc. (2008) Summary page 2.

## Most influential descendants
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (2015), 19 descendants of its own
- K162986: SPIRA Open Matrix ALIF (2017), 11 descendants of its own
- K180724: SPIRA Open Matrix LLIF (2018), 10 descendants of its own
- K190483: SPIRA Open Matrix ALIF and LLIF (2019), 9 descendants of its own
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120203
Methodology: https://510kreport.com/methodology