# K111119: Trabecular Metal (TM) Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Nov 23, 2011 after 216 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 9 generations back to K841189 (1984). 20 ancestors in all.
52 later devices descend from it; 6 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K132894: Optio-C Anterior Cervical System (2014), 24 descendants of its own
- K173077: Cavetto-SA Cervical Cage System (2018), 21 descendants of its own
- K200115: Cavetto-SA Cervical Cage System (2020), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K173159: Cervical Spinal Truss System (CSTS) Interbody Fusion Device (2018), 12 descendants of its own

## Indications for use
The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with! without radicular symptoms at one level from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic Studies. These patients should have had six weeks of non-operative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systemts and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

Source page: https://510kreport.com/device/K111119
Methodology: https://510kreport.com/methodology