(364 days)
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.
The NEST Interbody System is an intervertebral body fusion cage which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow, rectangular implant consists of both solid and porous structures and serrations on the superior and inferior porous surfaces are for enhanced fixation.
The implant is designed to be used with supplemental fixation with cleared for use in the lumbosacral spine. The implant is offered in a variety of sizes to accommodate a variety of patients' anatomy. NEST is additively manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile.
The provided text describes a medical device, the NEST Interbody System, and its 510(k) submission to the FDA. However, it does not contain specific acceptance criteria, reported device performance data, study details (like sample size, data provenance, expert qualifications, or adjudication methods), or information about AI assistance or standalone algorithm performance.
The document focuses on:
- Product Information: Device name, regulation number, regulatory class, product code, indications for use.
- Manufacturer Information: Company name, contact person, date prepared.
- Predicate Devices: Identifying legally marketed predicate devices for substantial equivalence.
- Device Description: General features, material (Ti6Al4V alloy), and intended use.
- Summary of Non-Clinical Testing: Mentioning compliance with FDA guidance and specific mechanical tests performed (Static Compression, Dynamic Compression, Static Compression Shear, Static Torsion, Subsidence per ASTM F2077 and F2267).
- Conclusion: Stating substantial equivalence based on design, materials, features, indications, and mechanical testing results.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details because it is not present in the provided text. The document pertains to a traditional 510(k) submission for a physical medical implant, not an AI/ML-driven device, so questions related to human reader improvement with AI assistance or standalone algorithm performance are not applicable based on the given information.
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Paonan Biotech Co., Ltd. Tony Lin R&D Engineer 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District, Taipei City 11491 Taiwan
Re: K180230
Trade/Device Name: NEST Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2018 Received: December 26, 2018
Dear Mr. Lin:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
January 25, 2019
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180230
Device Name NEST Interbody System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Reproduction (Part 21 CFR 301 Subpart B) | ☐ Over-The-Counter Use (OTC) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------ |
|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 Interbody System
Traditional 510(k)
K180230 510(k) Summary
| Submitted by | Paonan Biotech Co., Ltd.3F., No. 50, Lane 258, Rueiguang Road, Neihu District 11491, Taipei City, Taiwan |
|---|---|
| Contact Person | Tony LinR & D EngineerPhone: +886-2-26274366 #603Email: linzw@paonan.com.tw |
| Date Prepared | January 19th, 2018 |
| Common Name | Intervertebral body fusion device |
| Trade Name | NEST Interbody System |
| Proposed Class | Class II |
| Classification Name and Number | Intervertebral body fusion device, 21 CFR §888.3080 |
| Product Code | MAX |
| Predicate Devices | Legally marketed predicate devices to which substantial equivalence is claimed:Primary predicate:●Stryker Spine Tritanium® PL Cage (K152304)Additional predicate:●Spineart JULIET® Ti (K153621)K2M Cascadia Interbody System (K150481)DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spinal System(P960025) |
| Device Description | The NEST Interbody System is an intervertebral body fusion cage which canbe inserted between two lumbar or lumbosacral vertebral bodies to give supportand correction during lumbar interbody fusion surgeries. The hollow,rectangular implant consists of both solid and porous structures and serrations onthe superior and inferior porous surfaces are for enhanced fixation. |
| The implant is designed to be used with supplemental fixation with cleared for usein the lumbosacral spine. The implant is offered in a variety of sizesto accommodate a variety of patients' anatomy. NEST is additivelymanufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile. | |
| Intended Use and Indications for Use | The NEST Interbody System is indicated for interbody fusion with autografand/or allogenic bone graft comprised of cancellous and/or corticocancellous bonegraft in patients with degenerative disc disease (DDD) at one or twocontiguous levels from L2 to S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by patient history and radiographic studies.Patients should be skeletally mature and have six months of non-operativetreatment. The DDD patients may also have up to Grade 1 spondylolisthesis at theinvolved level(s). The NEST Interbody System is intended to be used withsupplemental spinal fixation systems that have been cleared for use in thelumbosacral spine |
| Summary of the TechnologicalCharacteristics | The subject NEST Cage and the predicates are identical in indications for use,surgical technique, manufacturing method and raw material. The subject NESTCage and the predicates share similar design features:Graft windows for packing autogenous bone Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles, material |
| Summary ofNon-Clinical Testing | Testing in compliance with: FDA's "Class II Special Controls GuidanceDocument: Intervertebral Body Fusion Device" was performed for the NEST Cageand demonstrated substantially equivalent performance to the identified predicatedevices.The following mechanical tests were performed:Static Compression (per ASTM F2077) |
| Dynamic Compression (per ASTM F2077)Static Compression Shear (per ASTM F2077)Static Torsion (per ASTM F2077)Subsidence (per ASTM F2267) | |
| Conclusion | Based on the design features, the use of established well known materials, featurcomparisons, indications for use, and results of the mechanical testing, theNEST Cage has demonstrated substantial equivalence to the identified predicatedevices. |
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Image /page/4/Picture/0 description: The image shows the logo for BIOMECH Paonan Biotech Co.,Ltd. The word "BIOMECH" is in large, gray, sans-serif font. Below it, the words "Paonan Biotech Co.,Ltd" are in a smaller, gray, sans-serif font. To the right of the word "BIOMECH" is a graphic of two curved shapes, one blue and one green.
Paonan Biotech Co., Ltd. NEST Interbody System
Traditional 510(k)
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Paonan Biotech Co., Ltd. NEST Interbody System Traditional 510(k)
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.