Corelink Foundation 3D Anterior Lumbar System

K180556 · Corelink, LLC · MAX · Jul 27, 2018 · Orthopedic

Device Facts

• Record ID: K180556
• Device Name: Corelink Foundation 3D Anterior Lumbar System
• Applicant: Corelink, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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.

Device Story

Additively manufactured titanium alloy (Ti-6AL-4V ELI) interbody cages; designed for anterior lumbar interbody fusion (ALIF). Cages feature porous architecture to facilitate bone growth; provide mechanical support to lumbar spine during arthrodesis. Implanted by surgeons in clinical settings; placed between vertebral bodies. Cages are open-centered to accept autogenous bone graft. System includes reusable instruments and sterilization tray. Benefits include mechanical stability and promotion of fusion in patients with DDD.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design verification testing and Finite Element Analysis (FEA) confirming that new sizes do not negatively impact mechanical performance, biocompatibility, or sterilization.

Technological Characteristics

Material: Titanium alloy Ti-6AL-4V ELI (ASTM F136). Manufacturing: Additive manufacturing (3D printing). Architecture: Fully porous with varying pore sizes. Dimensions: Footprints 25x35mm to 30x45mm; heights 10-21mm; lordosis 8° and 15°. Connectivity: None. Sterilization: Provided in sterilization tray.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (one level, C2-T1) or lumbar spine (one or two contiguous levels, L2-S1). Lumbar patients may have up to Grade I spondylolisthesis or retrolisthesis. Requires autograft bone and supplemental 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

• Corelink Foundation 3D Interbody (K162496)
• Corelink Foundation Lumbar Interbody Devices (K150847)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

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)

| <div> <span> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> <polyline points="2,2 8,8 14,2 14,3 8,9 2,3 2,2" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
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| <div> <span> <svg height="16" width="16"> <polygon points="1,0 15,0 15,14 1,14" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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, LLC<br>7911 Forsyth Blvd. Suite #200<br>St. Louis, MO 63105 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Vikki M. O'Connor<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | June 8, 2018 |
| Trade Name | Corelink Foundation 3D Anterior Lumbar System |
| Proposed Class | Class II |
| Classification Name<br>and Number | Intervertebral Fusion Device with Bone Graft, Lumbar<br>888.3080 |
| Common Name | Interbody Fusion Device |
| Product Code / Panel | MAX / Orthopedics |
| Predicate Device | Corelink Foundation 3D Interbody ">– K162496 (Primary<br>Predicate), Corelink Foundation Lumbar Interbody<br>Devices - K150847 |
| Special Controls | N/A |
| Purpose of Submission | To add additional Anterior Lumbar Interbody Cage<br>footprints / sizes to the existing system. |
| Device Description | The Foundation 3D Anterior Lumbar System is intended<br>to be used as interbody fusion devices.<br><br>The Foundation 3D Anterior Lumbar System consists of<br>additively manufactured interbody cages, re-usable<br>instruments and a sterilization tray. |
| | Foundation 3D Anterior Lumbar Cages are inserted<br>between vertebral bodies in the anterior column of the<br>lumbar spine. The new footprint / size cages are for this<br>lumbar indication. The cages are designed to provide<br>mechanical support to the lumbar spine while arthrodesis<br>occurs. The lumbar line features a wide variety of lordosis<br>and footprint options with fully porous architectures and<br>varying pore sizes to offer increased room for bone<br>growth with mechanical stability.<br><br>The Foundation 3D Anterior Lumbar System cages are<br>made from the Titanium alloy Ti-6AL-4V ELI<br>(conforming to ASTM F136 in terms of mechanical<br>properties only) and are open in the center to accept<br>autogenous bone graft material.<br><br>The new Anterior Lumbar Cages, which are the subject of<br>this 510k, are in sizes: 25mm x 35mm, 25mm x 40mm,<br>27mm x 35mm, 27mm x 40mm, 30mm x 40mm, and<br>30mm x 45mm. Each footprint offers cage heights ranging<br>from 10mm to 21mm in 1mm increments along with<br>lordosis angles of 8° and 15°. |
| Indications for Use | The Foundation 3D cervical implants are indicated for use<br>in skeletally mature patients with degenerative disc<br>disease (DDD) of the cervical spine with accompanying<br>radicular symptoms at one disc level. DDD is defined as<br>discogenic pain with degeneration of the disc confirmed<br>by patient history and radiographic studies. Foundation<br>Cervical implants are used to facilitate intervertebral body<br>fusion in the cervical spine and are placed via an anterior<br>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 |
| | 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 the<br>Technological<br>Characteristics | Foundation 3D Anterior Lumbar System cages possess<br>the same technological characteristics as the primary<br>predicate Foundation 3D Interbody Lumbar Cages<br>(K162496). These include: Indications for Use, Method of<br>manufacture, implant design, materials, method of<br>implantation, method of packaging and sterilization. The<br>new sizes do not add additional risks and do not<br>represent a new worst case. |
| Performance Data | Based on the risk analysis for the new implant sizes and<br>deign verification testing conducted on the Foundation 3D<br>Anterior Lumbar Cages, including Finite Element Analysis<br>(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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