The Tiger 2 System is a pedicle screw system 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 deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

Device Description

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

AI/ML Overview

The provided text is a 510(k) summary for the Tiger 2 System, a medical device for spinal fixation. It details the device's indications for use, materials, and mechanical testing results. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

The document primarily focuses on the substantial equivalence of the Tiger 2 System to a predicate device based on:

Mechanical Performance Data: Static and dynamic compression bending, and axial and torsional grip testing were performed according to ASTM F1717 and ASTM F1798.
Technological Characteristics: Basic design (rod-based fixation system with polyaxial pedicle screws), materials (titanium alloy, cobalt chrome), and intended use.

The "device" in this context is a physical pedicle screw system, not an AI or software-driven device. Therefore, the questions regarding AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document.

In summary, based solely on the provided text, it is not possible to answer the questions about acceptance criteria and study proving device meets acceptance criteria for an AI/software product. The document describes a traditional medical device clearance process focused on mechanical equivalence.

Summary

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February 3, 2025

Zavation Medical Products, LLC Frankie Cummins Chief Engineer 3670 Flowood Drive Flowood, Mississippi 39232

Re: K243908

Trade/Device Name: Tiger 2 System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB. KWO. KWP Dated: December 17, 2024 Received: December 19, 2024

Dear Frankie Cummins:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "EILEEN CADEL-S" in a stylized font. The words "EILEEN" and "CADEL" are stacked on top of each other, with "-S" to the right of "CADEL". The letters "EDA" are in the background in a light blue color.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243908

Device Name Tiger 2 System

Indications for Use (Describe)

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

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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510K Summary

Date:	January 31, 2025
Submitter:	Zavation Medical Products, LLC3670 Flowood DriveFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Frankie Cummins
Type of 510(k) submission:	Traditional
Trade name:	Tiger 2 System
Common name:	Spinal Fixation System
Classification regulation:	Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070 (NKB)Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 (KWQ)Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 (KWP)
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	NKB, KWQ, KWP
Basis for submission:	New submittal

Purpose: The purpose of this submission is to request clearance for the Tiger 2 System implants and instruments.

Device Description: The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

Indications for Use:

The Tiger 2 System is a pedicle screw system intended to provide Immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

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

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

Materials:

The Tiger 2 System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136, and cobalt chrome alloy (Co-28Cr-6Mo) as described by ASTM F1537.

Primary Predicate Device:

K222614 Zavation Spinal System [Zavation]

Performance Data:

Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 as well as axial and torsional grip testing per ASTM F1798 on a worst-case construct. The mechanical test results demonstrated substantial equivalency to the predicate device.

Comparison of Technological Characteristics:

The Tiger 2 System possesses the same technological characteristics as the predicate device. These include: basic design (rod based fixation system having polyaxial pedicle screws with various screw and rod diameters and lengths), material (titanium alloy, cobalt chrome), mechanical safety and performances, and intended use (as described above).

Substantial Equivalence Conclusion:

The Tiger 2 System devices are similar to the predicate system with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices.

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.