(29 days)
Not Found
No
The document describes a spinal implant and its mechanical properties, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which aims to provide therapeutic relief and restore spinal stability.
No
The device is an implantable cage designed for intervertebral body fusion procedures to provide mechanical support to the lumbar spine, not to diagnose a condition.
No
The device description explicitly states the device is an additively manufactured implant made from titanium alloy, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for intervertebral body fusion procedures in the lumbar spine. This is a therapeutic device used in vivo (within the body) to treat a medical condition (degenerative disc disease).
- Device Description: The device is described as an additively manufactured implant made from titanium alloy, designed to provide mechanical support to the spine. This aligns with the description of a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the F3D™ Lateral System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The F3D™ Lateral System is part of the Foundation 3D Interbody System. The purpose of this Special 510(k) is to add sizes and lordotic angles to the system. The cages are additively manufactured implants made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F136 specifications. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FEA was performed to demonstrate that the modified geometries of the cage did not change the worst case device in the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 19, 2018
Corelink, LLC % Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street Suite 1000 Washington, District of Columbia 20001
Re: K183239
Trade/Device Name: CoreLink F3D™ Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 20, 2018 Received: November 20, 2018
Dear Justin Eggleton:
We have reviewed vour 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
1
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 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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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
2
Indications for Use
510(k) Number (if known)
K183239
Device Name CoreLink F3D™ Lateral System
Indications for Use (Describe)
The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
| 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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3
510(k) Summary
| Device Trade Name: | CoreLink F3D™ Lateral System |
|---|---|
| Manufacturer: | CoreLink, LLC |
| 2072 Fenton Logistics Blvd. | |
| St. Louis, Missouri 63026 | |
| United States | |
| Contact: | Mr. Steven D. Mounts |
| Phone: (888) 349-7808 | |
| Prepared by: | Mr. Justin Eggleton |
| Senior Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: (202) 552-5804 | |
| jeggleton@mcra.com | |
| Date Prepared: | December 18, 2018 |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Codes: | MAX |
Primary Predicate Device: CoreLink Foundation 3D Interbody System (K162496)
Additional Predicate Device: Foundation Lateral Interbody System (K150847)
Indications for Use:
The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.
Device Description:
The F3D™ Lateral System is part of the Foundation 3D Interbody System. The purpose of this Special 510(k) is to add sizes and lordotic angles to the system. The cages are additively manufactured implants made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM
4
F136 specifications. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.
Performance Testing:
FEA was performed to demonstrate that the modified geometries of the cage did not change the worst case device in the system.
Substantial Equivalence:
The F3D™ Lateral System substantially equivalent to the predicate Foundation 3D Interbody System (K162496) with respect to intended use, materials, design, and performance characteristics. The information summarized in the Design Control Activities Summary demonstrates that the modified geometries of the cage meet the pre-determined acceptance criteria for the verification activities.