# K180230: NEST Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Jan 25, 2019 after 364 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: 19 generations back to K841189 (1984). 168 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152304: Tritanium PL Cage, Stryker (2015) Summary page 4.
- K153621: Juliet® Ti, Spineart (2016) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.

## Most influential descendants
- K220261: NEST-C Interbody System (2023), 0 descendants of its own

## Indications for use
The NEST Interbody System is indicated for interbody fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K180230
Methodology: https://510kreport.com/methodology