# K100210: TRANS1 Lateral Intervertebral Fusion Device, T

- Pathway: 510(k) (Traditional)
- Applicant: Trans1 Incorporated
- Decided: Aug 26, 2010 after 213 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: 10 generations back to K841189 (1984). 37 ancestors in all.
175 later devices descend from it; 3 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 1.
- K090425: Guided Lateral Interbody Fusion (Glif) System, Alphatec Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K123997: TRANS1LATERAL Interbody Fusion System (2013), 173 descendants of its own
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (2016), 171 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The TranSi Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS 1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

Source page: https://510kreport.com/device/K100210
Methodology: https://510kreport.com/methodology