The TIGER™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies). degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The TIGER™ Spine System is comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER The System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors. The implants are manufactured from Ti6Al4V alloy.

AI/ML Overview

This 510(k) summary describes a spinal implant system, not an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are specific to AI/ML device evaluations, cannot be provided.

The TIGER™ Spine System is a pedicle screw spinal system used for spinal immobilization and stabilization. The submission is for an expansion of its Indications For Use to include Degenerative Disc Disease (DDD).

The device's performance was evaluated through mechanical testing and comparison to predicate devices, not through a study involving AI/ML performance metrics.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing:	The TIGER™ Spine System was found to be substantially equivalent to predicate devices.
Static compression bending per ASTM F1717	Performed and results supported substantial equivalence.
Dynamic compression bending per ASTM F1717	Performed and results supported substantial equivalence.
Static torsion testing per ASTM F1717	Performed and results supported substantial equivalence.
Clinical Literature Analysis:	A clinical literature analysis was conducted to support the expanded Indications For Use.
Substantial Equivalence:	The TIGER™ Spine System was shown to be substantially equivalent to previously cleared devices (K110906 and K110321) with respect to its indications for use, design, function, and materials.

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 applicable as this is a mechanical medical device, not an AI/ML device that uses a test set of data. The "testing" refers to mechanical integrity and performance as per ASTM standards for spinal implants.

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 applicable. The device's "ground truth" is defined by its mechanical properties and performance against established ASTM standards for spinal implants, not by expert interpretation of data.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for mechanical testing of hardware.

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 applicable. This is a spinal implant system, not an AI-assisted diagnostic or clinical decision-making tool.

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

This information is not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for this device's performance is established by adherence to mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data in the context of an AI/ML model. The comparison is against previously cleared devices and their established performance and safety profiles.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an AI/ML device that uses a training set.

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

This information is not applicable as this is a mechanical medical device, not an AI/ML device.

Summary

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MAR 2 9 2012

510(k) Summary

Device Trade Name:	TIGER™ Spine System
Manufacturer:	Corelink, LLC10805 Sunset Office Drive, Suite 300St. Louis, MO 63127
Contact:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	September 28, 2011
Common Name:	Pedicle screw spinal system
Classification:	21 CFR 888.3070
Class:	III
Product Code:	NKB, MNH, MNI

Indications For Use:

Device Description:

The purpose of this 510(k) is to expand the Indications For Use statement to included Degenerative Disc Disease (DDD).

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K113058

Predicate Devices:

The TIGERTM Spine System was shown to be substantially equivalent to previously cleared devices (K110906 and K110321).

Substantial Equivalence:

Testing performed on this device indicates that the TIGER™ Spine System is substantially equivalent to predicate devices. Mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717, as well as, a clinical literature analysis.

Conclusion

The TIGER™ Spine System was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Corelink. LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

MAR 2 9 2012

Re: K113058

Trade/Device Name: TIGER(TM) Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI Dated: March 5, 2012 Received: March 6, 2012

Dear Mr. Eggleton:

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

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Page 2 - Mr. Justin Eggleton

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KI13058 510(k) Number (if known):

Device Name: TIGERTM Spine System

The TIGER™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K113058

Regulation Number and Section

N/A