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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

AI/ML Overview

This document does NOT describe a study that uses AI/ML to detect or diagnose a condition and does not contain the requested information. The document describes a Special 510(k) submission for the Tiger™ Spine System, which is a medical device (pedicle screw system) used for spinal fixation.

Here's why the requested information cannot be provided from this document:

Acceptance Criteria and Reported Device Performance (Table): The document reports non-clinical test results (static and dynamic compression, static torsion) and states that the results "indicate that the TIGER™ is equivalent to predicate device(s)." It does not provide specific numerical acceptance criteria or detailed performance metrics in the way one would for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The "performance" here relates to mechanical strength and equivalence.
Sample Size for Test Set and Data Provenance: Not applicable as no clinical study or AI/ML model evaluation involving human data was performed.
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states, "No clinical studies were performed." Therefore, no MRMC study was conducted.
Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
Type of Ground Truth Used: Not applicable. The "ground truth" for this device's evaluation was based on mechanical test standards (ASTM F1717) and demonstrating equivalence to predicate devices, not clinical outcomes or expert consensus on a diagnosis.
Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as no AI/ML model was developed or trained.

In summary, this document is a regulatory submission for a physical medical device, not a diagnostic algorithm. The "study" referenced is non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Summary

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K120696 Page 1 of 2

Special 510(k) Summary for the Tiger™ Spine System

APR - 2 2012

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following Special 510(k) summary is submitted for the Tiger™ Spine System

1. GENERAL INFORMATION

Date Prepared:	February 29, 2012
Trade Name:	TIGER™ Spine System
Common Name:	pedicle screw system
Classification Name:	orthosis, spinal pedicle fixationorthosis, spondylolisthesis spinal fixation
Class:	II
Product Code:	MNIMNH
CFR section:	21 CFR section 888.3070
Device panel:	Orthopedic
Legally Marketed	TIGER™ Spine System (K110321)
Predicate Device:	Viper™ Spine System (K061520/K111571)Synergy VLS - open (K000236)DePuy Spine - Moss Miami SS (K950697)DePuy Spine - Moss Miami (K955348)Viper - DePuy (K061520/K111571)Click'X - Synthes (K992739)Pangea - Synthes (K052123)
Submitter:	Corelink, LLC10805 Sunset Office Drive, Suite 300St. Louis, MO 63127
Contact:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199e-mail: jdwebb@orthomedix.net

2. DEVICE DESCRIPTION

The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

Change from Predicate:

The purpose of this submission is to make modifications/additions to the components of the TIGER™ Spine System cleared in K110321. The standard construct is modified by the addition of a variety of additional/modified screws and rods.

3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

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The TIGER™ Spine System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

4. INTENDED USE

5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

Static and dynamic compression per ASTM F1717 .
Static torsion per ASTM F1717 .

The results of this testing indicate that the TIGER™ is equivalent to predicate device(s).

6. CLINICAL TEST SUMMARY

No clinical studies were performed

7. CONCLUSIONS NONCLINICAL AND CLINICAL

This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the TIGER™ System is as safe, as effective, and performs as well or as better than the predicate device(s).

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Corelink, LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

APR - 2 2012

Re: K120696

Trade/Device Name: Tiger™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: February 29, 2012 Received: March 7, 2012

Dear Mr. Webb:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. J.D. Webb

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/CDRH/CDRHOffices/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/Resourcesfor You/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

510(k) Number (if known): K120696

Device Name: TIGER " Spine System

Indications for Use:

The TIGER"" Spine System is intended to provide immobilization 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Prescription Use_ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

KI 20696 510(k) Number_

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.