# K233075: “BioGend” Interbody Fusion System 001 Cage

- Pathway: 510(k) (Traditional)
- Applicant: Biogend Therapeutics Co., Ltd.
- Decided: Mar 6, 2024 after 162 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: 12 generations back to K841189 (1984). 41 ancestors in all.
No later device cites it as a predicate yet.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180228: II-Type Intervertebral Spacer, Paonan Biotech Co., Ltd. (2019) Summary page 4.

## Indications for use
The “BioGend” Interbody Fusion System 001 Cage 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. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. “BioGend” Interbody Fusion System 001 Cage is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine

Source page: https://510kreport.com/device/K233075
Methodology: https://510kreport.com/methodology