# K113478: Plif Cage

- Pathway: 510(k) (Abbreviated)
- Applicant: Eisertech, LLC
- Decided: Mar 5, 2012 after 103 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: 11 generations back to K003155 (2001). 52 ancestors in all.
269 later devices descend from it; 8 cite it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 3.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 3.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.

## Most influential descendants
- K140348: Interbody Cage (2015), 235 descendants of its own
- 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

## Indications for use
The PLIF Cage is indicated for use with autogenous bone graft in patients with, degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DOD 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/K113478
Methodology: https://510kreport.com/methodology