# K092162: 4CIS Peek, Plif and Tlif Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Solco Biomedical Co., Ltd.
- Decided: Jan 6, 2010 after 174 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
No predicates in its family tree.
49 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage (2011), 38 descendants of its own
- K120063: Venus Lumbar Intervertebral Body Fusion Cage System (2012), 37 descendants of its own
- K121096: Venus Lumbar Intervertebral Body Fusion Cage System (2012), 36 descendants of its own
- K151140: LnK Lumbar Interbody Fusion Cage System (2015), 29 descendants of its own
- K181380: LnK Lumbar Interbody Fusion Cage System (2018), 10 descendants of its own

## Indications for use
The 4CISO PEEK PLIF is intervertebral body fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 4CISO PEEK PLIF TM IBF device is intended to be used with autologous bone graft to facilitate fusion. The 4CIS® PEEK PLIF TM IBEF device is to be used in patients, who have had six months of non-operative treatment. The device is to be implanted via a direct posterior approach. The 4018® PEEK PLIF TM device may be implanted singly or in pairs in the lumbosacral spine with supplemental fixation.

Source page: https://510kreport.com/device/K092162
Methodology: https://510kreport.com/methodology