NEST-C Interbody System

K220261 · Paonan Biotech Co., Ltd. · ODP · Apr 24, 2023 · Orthopedic

Device Facts

• Record ID: K220261
• Device Name: NEST-C Interbody System
• Applicant: Paonan Biotech Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Apr 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

NEST-C Interbody System is a spinal implant for cervical interbody fusion; manufactured via additive manufacturing (3D printing) using titanium alloy powder. Implant features hollow window and internal porous structure for bone graft packing; serrated superior/inferior surfaces for fixation. Available in various footprints, heights, and lordotic angles. Used by surgeons in clinical settings; requires supplemental spinal fixation. Provides structural support for fusion; benefits patients with degenerative disc disease by stabilizing the spinal segment.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-22 and F2267-04, including static compression, static compression shear, static torsion, dynamic compression, and dynamic torsion. Biocompatibility evaluation conducted per ISO 10993-1.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V ELI) per ASTM F3001. Manufacturing: Additive manufacturing. Design: Hollow window, internal porous structure, serrated superior/inferior surfaces. Form factor: Various footprints, heights, and lordotic angles. Sterilization: Not specified.

Indications for Use

Indicated for cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) at one or multiple contiguous levels (C2-T1). Requires six weeks of prior non-operative treatment. Must be used with supplemental spinal fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• AVS® AS PEEK Spacer (K142251)
• NEST Interbody System (K180230)

Submission Summary (Full Text)

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April 24, 2023

Paonan Biotech Co., Ltd. Penny Huang Associate Product Manager 3F, No.50, Lane 258, Rueiguang Road, Neihu District Taipei City, 114062 Taiwan

Re: K220261

Trade/Device Name: NEST-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 22, 2023 Received: March 22, 2023

Dear Penny Huang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K220261

Device Name NEST-C Interbody System

#### Indications for Use (Describe)

The NEST-C Interbody System is indicated for use in cervical interbody fusion procedures with autogenous bone graff and/or allogenic bone graft comprised of cancellous 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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Paonan Biotech Co., Ltd. NEST-C Interbody System Traditional 510(k)

### 510(k) Summary

| Submitted by | Paonan Biotech Co., Ltd. | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 3F., No. 50, Lane 258, Rueiguang Road, Neihu District 11491, Taipei | |
| | City, Taiwan | |
| Contact Person | Penny Huang | |
| | Phone: [phone] #608 | |
| | Email: [e-mail] | |
| Date Prepared | Jan.26,2022 | |
| Common Name | Intervertebral body fusion device | |
| Trade Name | NEST-C Interbody System | |
| Proposed Class | Class II | |
| Classification Name and Number | Intervertebral body fusion device, 21 CFR §888.3080 | |
| Product Code | ODP | |
| Predicate Devices | Legally marketed predicate devices to which substantial equivalence is claimed: Primary predicate:<br>AVS® AS PEEK Spacer (k142251) Additional predicate:<br>NEST Interbody System (k180230) | |
| Device Description | The NEST-C Interbody System is intervertebral body fusion device with solid and porous structures that both are simultaneously built using additive manufacturing method, from titanium alloy (Ti6Al4V ELI) powder per ASTM F3001. Offered in a number of footprints heights and lordotic angles to adapt to a variety of patient anatomies. The implant consists of a hollow window for bone graft packing and serrations on the superior/inferior surfaces of the cage for enhanced fixation. The internal porous structure provides additional space for bone graft packing. NEST-C cage is intended to be used with supplemental spinal fixation | |
| | systems that have been cleared for use in the cervical spine. | |
| Intended Use and Indications for Use | The NEST-C Interbody System is indicated for use in cervical<br>interbody fusion procedures with autogenous bone graft and/or<br>allogenic bone graft comprised of cancellous and/or corticocancellous<br>bone graft in skeletally mature patients with degenerative disc disease<br>(DDD) at one level or multiple contiguous levels from the C2 to T1<br>disc. DDD is defined as neck pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies. Patients should be skeletally mature and have six weeks of<br>non-operative treatment.<br>The NEST-C Interbody System is intended to be used with<br>supplemental spinal fixation systems that have been cleared for use in<br>the cervical spine. | |
| Summary of the Technological<br>Characteristics | The subject NEST-C Interbody System and the predicates are identical<br>in indications for use, surgical technique, manufacturing method and<br>raw material.<br>The subject NEST-C Cage and the predicates share similar design<br>features:<br>Hollow structure for packing autogenous bone graft and/or<br>allogenous bone graft. Serrations on the superior and inferior surfaces Comparable heights, widths, lengths and material | |
| Summary of<br>Non-Clinical Testing | The worst case devices were subjected to mechanical testing. Testing<br>included static compression, static compression shear, static torsion,<br>dynamic compression, dynamic torsion, and subsidence per ASTM<br>F2077-22 and F2267-04.<br>NEST-C Interbody System is the same as the predicate device NEST<br>Interbody System in formulation, manufacturing processing,<br>sterilization, and geometry. According to biocompatibility evaluation,<br>current submission met the biocompatibility requirements of ISO | |
| | 10993-1 and is safe for clinical use.<br>These results demonstrate that the devices are substantially equivalent<br>to the identified predicate devices. | |
| Conclusion | NEST-C Interbody System has demonstrated substantial equivalence<br>to the identified predicate devices regarding the design features,<br>materials used, manufacturing, sterilization, indications for use, and<br>results of the mechanical testing. | |

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Paonan Biotech Co., Ltd. NEST-C Interbody System Traditional 510(k)

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Image /page/5/Picture/1 description: The image shows the logo for BIOMECH Paonan Biotech Co.,Ltd. The word "BIOMECH" is written in a sans-serif font in gray color. Below the word "BIOMECH" is the text "Paonan Biotech Co.,Ltd" in a smaller font size. To the right of the word "BIOMECH" are two curved shapes, one in blue and one in green.

Paonan Biotech Co., Ltd.

## NEST-C Interbody System

Traditional 510(k)