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NEST Interbody System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180230

by Paonan Biotech Co., Ltd.

Identifiers

510(k) Number
K180230 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NEST Interbody System is a hollow, rectangular interbody fusion device designed for spinal arthrodesis. Its composite architecture combines solid and porous titanium structures, mimicking cancellous bone microstructure to facilitate bone in-growth and biological fixation within the lumbar spine.

This system is supplied as a single-use, sterile device and is intended for use in surgical settings. Manufactured via 3D printing technology, it is classified under FDA 510(k) clearance (K180230) as substantially equivalent to a predicate device under the Traditional 510(k) pathway. Sizes and configurations are detailed in the accompanying technical documentation.

Frequently asked questions

What types of spinal procedures is the NEST Interbody System designed for, and how does its design support bone integration?

The NEST Interbody System is specifically designed for lumbar spine arthrodesis, a surgical procedure to fuse vertebrae and stabilize the spine. Its composite architecture—combining solid and porous titanium—mimics cancellous bone microstructure, which promotes bone in-growth and biological fixation. This design enhances long-term stability by encouraging natural bone integration within the interbody space.

Is the NEST Interbody System reusable, or is it intended for single-use only? How does this affect its clinical workflow?

The NEST Interbody System is explicitly supplied as a single-use, sterile device, meaning each unit is intended for one surgical procedure only. This design choice eliminates the need for sterilization between cases, simplifying workflow and reducing the risk of cross-contamination. Clinicians should follow the manufacturer’s instructions for handling to ensure sterility is maintained.

What size options are available for the NEST Interbody System, and how are they determined for a patient?

The available sizes and configurations for the NEST Interbody System are detailed in the accompanying technical documentation, as the exact dimensions are not provided in the data. Typically, interbody devices are selected based on the patient’s anatomical measurements (e.g., intervertebral space height and width) to ensure proper fit and stability. Preoperative imaging is essential to determine the appropriate size for optimal placement and fusion outcomes.

How should the NEST Interbody System be stored to maintain its integrity and sterility before use?

Since the NEST Interbody System is sterile and single-use, it must be stored in its original packaging under controlled conditions to preserve sterility. The manufacturer’s instructions (referenced in the technical documentation) should specify storage requirements, such as temperature ranges and protection from moisture or contamination. Proper storage ensures the device remains ready for immediate use in the operating room without compromising its sterile field.

What manufacturing process is used for the NEST Interbody System, and how does it contribute to its performance?

The NEST Interbody System is manufactured using 3D printing technology, which allows for precise, customizable designs with complex geometries—such as the porous titanium structure—that mimic natural bone. This process enables consistent production of the composite architecture, ensuring reliable bone in-growth and mechanical stability for spinal fusion procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEST - Product - BIOMECH-Total Spine solution, Innovative, Quality ..., PDF NEST Cat E v1.3 (20221221) 4p - neurospineproductreview.com, Smart Homes start with Google Nest

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Paonan Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K180230 24 fields · synced Sep 19, 2026