# K213441: PathLoc Lumbar Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Mar 9, 2022 after 135 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: 16 generations back to K841189 (1984). 91 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113447: Rise Spacer, Globus Medical, Inc. (2012) 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
- K251741: PathLoc Lumbar Interbody Fusion Cage System (2025), 0 descendants of its own
- K242829: BluEX Lumbar Expandable Cage System (2024), 0 descendants of its own

## Indications for use
PathLoc Lumbar Interbody 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 L.2-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. PathLoc Lumbar Interbody 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/K213441
Methodology: https://510kreport.com/methodology