# K180228: II-Type Intervertebral Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Jan 11, 2019 after 350 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: 11 generations back to K841189 (1984). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K103111: Forza Spacer System, Orthofix, Inc. (2011) Summary page 4.

## Most influential descendants
- K233075: “BioGend” Interbody Fusion System 001 Cage (2024), 0 descendants of its own

## Indications for use
The II-Type Intervertebral Spacer 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. The II-Type Intervertebral Spacer 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/K180228
Methodology: https://510kreport.com/methodology