# K223474: PathLoc-TA Expandable Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jan 13, 2023 after 56 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: 24 generations back to K841189 (1984). 369 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 371 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221719: ABTross ALIF Expandable Cage System, Aegis Spine, Inc. (2022) Summary page 4.

## Most influential descendants
- K242829: BluEX Lumbar Expandable Cage System (2024), 0 descendants of its own

## Indications for use
PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices ( 20° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K223474
Methodology: https://510kreport.com/methodology