# K190708: AccelFix Lumbar Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Sep 16, 2019 after 181 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: 21 generations back to K841189 (1984). 235 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173182: ProLift® Expandable System, Life Spine, Inc. (2017) Summary page 4.
- K171425: Concorde Lift, Medos International SARL (2017) Summary page 4.
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage, L&K BIOMED Co., Ltd. (2011) Summary page 4.
- K120063: Venus Lumbar Intervertebral Body Fusion Cage System, L&K BIOMED Co., Ltd. (2012) Summary page 4.
- K121096: Venus Lumbar Intervertebral Body Fusion Cage System, L&K BIOMED Co., Ltd. (2012) Summary page 4.
- K151140: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K181380: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K203531: XYPAN Expandable Lumbar Cage System (2021), 3 descendants of its own
- K221719: ABTross ALIF Expandable Cage System (2022), 2 descendants of its own
- K231680: AccelFix Lumbar Expandable Cage System (2023), 1 descendant of its own
- K223474: PathLoc-TA Expandable Lumbar Cage System (2023), 1 descendant of its own
- K242829: BluEX Lumbar Expandable Cage System (2024), 0 descendants of its own

## Indications for use
AccelFix Lumbar Expandable 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-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable 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/K190708
Methodology: https://510kreport.com/methodology