The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to firstien for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I vertebra 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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 tordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

AI/ML Overview

Here's the analysis of the provided text regarding the Range Spinal System:

This document is a 510(k) summary for component modifications to an existing device, the Range Spinal System. It does not describe a clinical study in the traditional sense, but rather a mechanical testing comparison to establish substantial equivalence with predicate devices. Therefore, many of the requested categories related to clinical studies and expert review will not be applicable.

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	The modified components of the Range Spinal System must perform equally to or better than the predicate devices in static compression, static torsion, and dynamic compression. This testing is to be conducted in accordance with ASTM F1717. (This is inferred from "The modifications to the Range Spinal System were mechanically tested and compared to predicate devices. The modified component performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.")	The modified component performed equally to or better than the predicate systems in static compression, static torsion, and dynamic compression.
Substantial Equivalence	Design Features: Similar to predicate devices. (Inferred from "The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.") Function: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") Material: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") Intended Use: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.")	The Range Spinal System's design features and sizing were found to be substantially the same as predicate systems. The device maintains substantial equivalence to other devices in design, function, material, and intended use. There are no significant differences that would adversely affect product use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This was a mechanical engineering test on components, not a clinical study on human subjects or clinical data. The "sample" would be the number of test articles (modified components) subjected to mechanical loads, which is not specified but would follow ASTM F1717 guidelines.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective. The data comes from mechanical laboratory testing of device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for mechanical performance tests is established by adhering to standardized testing protocols (e.g., ASTM F1717) and engineering measurements, not by expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a clinical study involving human readers or assessment of AI performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is not an AI/algorithm-based device.

7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements of force, displacement, cycles to failure, and other mechanical properties obtained through standardized testing methods (ASTM F1717). The performance of the predicate devices under these same conditions serves as the benchmark.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary

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KII2037

OCT - 6 2011

510(k) Summary for the Range Spinal System: Component Modifications

This 510(k) summary for the Range Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Submitter : K2M, Inc. 751 Miller Drive SE, Suite F ! Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc, Telephone: 703-777-3155

Date Prepared: 09/09/11

2. Tradename:	Range Spinal System
Common Name:	Spinal Fixation System
Classification Name:	Pedicle Screw Spinal System (21CFR 888.3070)
	Spinal Interlaminal Fixation Orthosis (21CFR 888.3050)
	Orthosis, Spondylolisthesis Spinal Fixation (21CFR 888.3070)
Device Product Code:	MNI, KWP, MNH
Regulatory Class:	Class II

Predicate or legally marketed devices which are substantially equivalent :

K2M Range Spinal System (K070229, K080792, K081381) ●
K2M Mesa Spinal System (K052398, K080611) .
K2M Denali Spinal System (K042635) .
DePuy Viper (K061520) .

4. Description of the device:

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

5. Intended Use:

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

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K112037

(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 tordosis); tumor; pseudoarthrosis; and failed previous fusion.

1. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.
1. Comparison of the performance data of the device to predicate and legally marketed devices : The modifications to the Range Spinal System were mechanically tested and compared to predicate devices. The modified component performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.

8. Conclusion:

There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

Ps 2 of 2

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an eagle or a person with outstretched arms, composed of three curved lines.

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

K2M. Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

Re: K112037

Trade/Device Name: Range Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: September 09. 2011 Received: September 13, 2011

0CI - 6 2011

Dear Ms. Giezen:

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. Youncil comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2- Ms. Nancy Giezen

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 (OS) 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/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/ReportalProblem/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.

urs,

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

Enclosure

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KII 2037

Indications for Use

510(k) Number (if known):

Device Name: Range Spinal System

Indications for Use:

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to following indications: degenerative disc disease (DDD ) (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.

Prescription Use X (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_________________________________________________________________________________________________________________________________________________________________

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.