# K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Oct 24, 2011 after 217 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: 9 generations back to K003155 (2001). 39 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 1.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K053508: Synfix-LR, Synthes Spine Co.Lp (2006) Summary page 1.
- K062083: Synfix -LR, Synthes Spine Co.Lp (2007) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 1.
- K101720: Juliet OL, Spineart (2010) Summary page 1.
- K092162: 4CIS Peek, Plif and Tlif Cage System, Solco Biomedical Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- 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
- K160976: Altus Spine Interbody Fusion System (2017), 8 descendants of its own

## Indications for use
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI. DOD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may also have up to Grade I spdndylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K110783
Methodology: https://510kreport.com/methodology