Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Foundation 3D lumbar implants are 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 Foundation 3D Anterior Lumbar System is intended to be used as interbody fusion devices.

The Foundation 3D Anterior Lumbar System consists of additively manufactured interbody cages, re-usable instruments and a sterilization tray.

Foundation 3D Anterior Lumbar Cages are inserted between vertebral bodies in the anterior column of the lumbar spine. The new footprint / size cages are for this lumbar indication. The cages are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar line features 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.

The Foundation 3D Anterior Lumbar System cages are made from the Titanium alloy Ti-6AL-4V ELI (conforming to ASTM F136 in terms of mechanical properties only) and are open in the center to accept autogenous bone graft material.

The new Anterior Lumbar Cages, which are the subject of this 510k, are in sizes: 25mm x 35mm, 25mm x 40mm, 27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and 30mm x 45mm. Each footprint offers cage heights ranging from 10mm to 21mm in 1mm increments along with lordosis angles of 8° and 15°.

AI/ML Overview

This document is a 510(k) premarket notification for the Corelink Foundation 3D Anterior Lumbar System. The submission concerns the addition of new Anterior Lumbar Interbody Cage footprints/sizes to an existing system. As such, the document primarily discusses substantial equivalence to predicate devices rather than detailing a new study with acceptance criteria for a novel device.

Therefore, the specific information requested cannot be fully extracted as it pertains to a performance study for a new device, which is not the subject of this 510(k).

However, based on the provided text, here's what can be stated regarding the device and its compliance:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or reported performance metrics for a clinical study. Instead, it states that:

Acceptance Criteria Category	Reported Device Performance (Assessment)
Mechanical Testing	No additional performance data was necessary for the new sizes, as they do not represent a new worst-case test condition. This was determined based on risk analysis and design verification testing, including Finite Element Analysis (FEA).
Sterilization	No additional performance data was necessary.
Biocompatibility	No additional performance data was necessary.
Shelf Life	No additional performance data was necessary.
Cleaning	No additional performance data was necessary.
Packaging	No additional performance data was necessary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is for additional sizes of an existing device and leverages prior testing and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document, as no such clinical study with ground truth established by experts is described for this specific 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The device is a physical interbody fusion cage, not an AI-assisted diagnostic or treatment system, so an MRMC study is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. The device is a physical interbody fusion cage, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" in the context of this device.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary

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July 27, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and consists of a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Corelink, LLC % Vikki M. O'Connor Regulatory Affairs Consultant Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, Florida 32043

Re: K180556

Trade/Device Name: Corelink Foundation 3D Anterior Lumbar System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 8, 2018 Received: June 29, 2018

Dear Vikki M. O'Connor:

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

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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,

Brent Showalter -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) K180556

Device Name

Corelink Foundation 3D Anterior Lumbar System

Indications for Use (Describe)

Foundation 3D lumbar implants are 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 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 nonoperative treatment prior to treatment with an intervertebral cage.

Type of Use (Select one or both, as applicable)

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

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510(k) Summary: Corelink Foundation 3D Anterior Lumbar System

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:

Submitter:	Corelink, LLC7911 Forsyth Blvd. Suite #200St. Louis, MO 63105
Contact Person	Ms. Vikki M. O'ConnorRegulatory Affairs ConsultantPhone: 1-207-214-8535Email: vikki0730@yahoo.com
Date Prepared	June 8, 2018
Trade Name	Corelink Foundation 3D Anterior Lumbar System
Proposed Class	Class II
Classification Nameand Number	Intervertebral Fusion Device with Bone Graft, Lumbar888.3080
Common Name	Interbody Fusion Device
Product Code / Panel	MAX / Orthopedics
Predicate Device	Corelink Foundation 3D Interbody ">– K162496 (PrimaryPredicate), Corelink Foundation Lumbar InterbodyDevices - K150847
Special Controls	N/A
Purpose of Submission	To add additional Anterior Lumbar Interbody Cagefootprints / sizes to the existing system.
Device Description	The Foundation 3D Anterior Lumbar System is intendedto be used as interbody fusion devices.The Foundation 3D Anterior Lumbar System consists ofadditively manufactured interbody cages, re-usableinstruments and a sterilization tray.
	Foundation 3D Anterior Lumbar Cages are insertedbetween vertebral bodies in the anterior column of thelumbar spine. The new footprint / size cages are for thislumbar indication. The cages are designed to providemechanical support to the lumbar spine while arthrodesisoccurs. The lumbar line features a wide variety of lordosisand footprint options with fully porous architectures andvarying pore sizes to offer increased room for bonegrowth with mechanical stability.The Foundation 3D Anterior Lumbar System cages aremade from the Titanium alloy Ti-6AL-4V ELI(conforming to ASTM F136 in terms of mechanicalproperties only) and are open in the center to acceptautogenous bone graft material.The new Anterior Lumbar Cages, which are the subject ofthis 510k, are in sizes: 25mm x 35mm, 25mm x 40mm,27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and30mm x 45mm. Each footprint offers cage heights rangingfrom 10mm to 21mm in 1mm increments along withlordosis angles of 8° and 15°.
Indications for Use	The Foundation 3D cervical implants are indicated for usein skeletally mature patients with degenerative discdisease (DDD) of the cervical spine with accompanyingradicular symptoms at one disc level. DDD is defined asdiscogenic pain with degeneration of the disc confirmedby patient history and radiographic studies. FoundationCervical implants are used to facilitate intervertebral bodyfusion in the cervical spine and are placed via an anteriorapproach at one disc level (C2-T1)

	using autograft bone. Foundation 3D Interbody implants
	are to be used with supplemental fixation. Patients should
	have at least six (6) weeks of non-operative treatment
	prior to treatment with an intervertebral cage.
	The Foundation 3D lumbar implants are 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.
Summary of theTechnologicalCharacteristics	Foundation 3D Anterior Lumbar System cages possessthe same technological characteristics as the primarypredicate Foundation 3D Interbody Lumbar Cages(K162496). These include: Indications for Use, Method ofmanufacture, implant design, materials, method ofimplantation, method of packaging and sterilization. Thenew sizes do not add additional risks and do notrepresent a new worst case.
Performance Data	Based on the risk analysis for the new implant sizes anddeign verification testing conducted on the Foundation 3DAnterior Lumbar Cages, including Finite Element Analysis(FEA), it was determined that inclusion of these new sizes
	new worst-case test condition for mechanical testing,
	performance testing, sterilization, biocompatibility, shelf
	life, cleaning or packaging. Therefore, in accordance with
	the design control process, additional performance data
	was not necessary for the changes subject of this
	Special 510(k).
Difference between	The only difference between the subject and predicate
Subject and Predicate	devices are the addition of new lumbar sizes.
Conclusion	Based on the indications for use, technological
	characteristics, materials, required performance testing,
	principles of operation, anatomical site, safety
	characteristics and comparison to the predicate device,
	Corelink's Foundation 3D Interbody Anterior Lumbar
	Cages have been shown to be substantially equivalent to
	the legally marketed predicate device.

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Regulation Number and Section

§ 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.