# K140348: Interbody Cage

- Pathway: 510(k) (Traditional)
- Applicant: Eisertech, LLC
- Decided: Apr 23, 2015 after 436 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: 12 generations back to K003155 (2001). 63 ancestors in all.
235 later devices descend from it; 4 cite it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113478: Plif Cage, Eisertech, LLC (2012) Summary page 5.
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd), Titan Spine, LLC (2009) Summary page 5.
- K090425: Guided Lateral Interbody Fusion (Glif) System, Alphatec Spine, Inc. (2009) Summary page 5.

## Most influential descendants
- K163506: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System (2017), 224 descendants of its own
- K173153: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System (2017), 160 descendants of its own
- K181860: NuVasive Cohere Thoracolumbar Interbody System (2018), 159 descendants of its own
- K193541: NuVasive Cohere Thoracolumbar Interbody System (2020), 157 descendants of its own
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (2020), 156 descendants of its own

## Indications for use
The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K140348
Methodology: https://510kreport.com/methodology