# K220261: NEST-C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Apr 24, 2023 after 448 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 20 generations back to K841189 (1984). 174 ancestors in all.
No later device cites it as a predicate yet.
1 of 175 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142251: AVS AS PEEK Spacer, Stryker Corporation (2014) Summary page 4.
- K180230: NEST Interbody System, Paonan Biotech Co., Ltd. (2019) Summary page 4.

## Indications for use
The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or multiple contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have six weeks of non-operative treatment. The NEST-C Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K220261
Methodology: https://510kreport.com/methodology