The CorticaLINK Fusion System is intended for noncervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

· degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

· spondylolisthesis;

· trauma (i.e., fracture or dislocation);
· spinal stenosis;
· curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
· tumor:
· pseudoarthrosis;
· and failed previous fusion.

Device Description

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws, rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "CorticaLINK Spinal Fusion Platform." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study that proves the device meets specific acceptance criteria through a performance study.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be fully addressed from the provided text because these elements are not present in a 510(k) for a device like this, which relies on substantial equivalence to a previously cleared predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment focuses on the modifications substantially meeting established criteria for the cleared parent device.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance (Summary from text)
N/A (Not explicitly stated as quantitative acceptance criteria for a performance study)	"substantially meets the performance criteria established for the cleared parent device"
	"The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device."

2. Sample size used for the test set and the data provenance

The document describes a submission for demonstrating substantial equivalence, not a clinical trial with a "test set" of patients or data in the typical sense. Therefore:

Sample size for test set: Not applicable (no test set of clinical data described).
Data provenance: Not applicable (no specific clinical data provenance mentioned for a new study). The comparison is primarily based on device characteristics and the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As there's no described clinical "test set" requiring ground truth establishment by experts for performance evaluation, this information is not provided. The submission focuses on engineering and material equivalence.

4. Adjudication method for the test set

Not applicable. There is no described test set of clinical cases or data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. This is a 510(k) for a spinal fusion platform, which typically demonstrates substantial equivalence through mechanical testing and comparison of design/materials, not through MRMC studies.

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

Not applicable. This device is a physical medical implant (spinal fusion platform), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The type of ground truth used

Not applicable. There is no described clinical study or algorithm where "ground truth" (e.g., pathology, outcomes data) would need to be established for performance evaluation. The "ground truth" in this context refers to the characteristics and performance of the predicate device to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical implant and does not involve AI/ML or a training set.

Summary

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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 is a blue square with the letters "FDA" in white. The words "U.S. Food & Drug Administration" are written in blue to the right of the square.

December 11, 2017

LinkSPINE, Inc. Mr. Nickolas G. Kriska Director of Engineering 5950 Symphony Woods Road, Suite 620 Columbia, Maryland 21044

Re: K173484

Trade/Device Name: CorticaLINK Spinal Fusion Platform Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 14, 2017 Received: November 15, 2017

Dear Mr. Kriska:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Ronald P. Jean -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)

K173484

Device Name CorticaLINK Spinal Fusion Platform

Indications for Use (Describe)

· degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

· spondylolisthesis;

· trauma (i.e., fracture or dislocation);
· spinal stenosis;
· curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
· tumor:
· pseudoarthrosis;
· and failed previous fusion.

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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510(k) Summary

ADMINISTRATIVE INFORMATION

Manufacturer Name:	LinkSPINE, Inc.(formerly known as FacetLINK Inc. dba Linkspine)5950 Symphony Woods Rd.Suite 620Columbia, MD 21044Telephone (410) 772-5465
Official Contact:	Nickolas G. KriskaDirector of Engineering
Date Prepared:	November 8, 2017
DEVICE NAME
Trade/Proprietary Name:	CorticaLINK Spinal Fusion Platform
Classification Panel:	Division of Orthopedic Devices
Common Name:	Thoracolumbosacral Pedicle Screw System

Classification:	Class II per 21 CFR §888.3070
Product Code(s):	NKB

ESTABLISHMENT REGISTRATION NUMBER

The LinkSPINE, Inc. (formerly known as FacetLINK Inc. dba Linkspine) establishment registration number is 3009442592.

INTENDED USE

The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis;
trauma (i.e., fracture or dislocation);
spinal stenosis;
curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
tumor;
pseudoarthrosis:
and failed previous fusion.

DEVICE DESCRIPTION

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical

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decompression. The platform is comprised of screws, rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

EQUIVALENCE TO MARKETED PRODUCT

LinkSPINE, Inc. has submitted information to demonstrate that, for the purposes of FDA's requlation of medical devices, the CorticaLINK Spinal Fusion Platform is substantially equivalent to the predicate device based on a comparison including the following characteristics:

FDA Product Code
Intended Uses
Anatomical Region
Implant Materials
Product Features

PRIMARY PREDICATE DEVICE

. LinkSPINE, Inc. - CorticaLINK Spinal Fusion Platform (K160722)

PERFORMANCE COMPARISON

LinkSPINE, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the CorticaLINK Spinal Fusion Platform modifications substantially meets the performance criteria established for the cleared parent device.

The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device.

Regulation Number and Section

N/A