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 skelctally 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, in skeletally mature patients, 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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

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.

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

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

The purpose of this submission is to add modified Small Stature components (screws, hooks and connectors) to the system.

AI/ML Overview

The provided text describes a 510(k) submission for the Range Spinal System, focusing on adding modified Small Stature components. This is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of an AI algorithm or diagnostic device. Therefore, much of the requested information (e.g., acceptance criteria for a diagnostic device, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth details) is not applicable to this document.

However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance) and the study that demonstrates it meets these criteria based on the provided text.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance)	Reported Device Performance
Substantial equivalence to predicate devices in:	The modified implants were determined to be substantially equivalent to the predicate devices.
- Static compression performance (in accordance with ASTM)	The modified implants were compared with predicate devices that were previously tested in static compression.
- Static torsion performance (in accordance with ASTM)	The modified implants were compared with predicate devices that were previously tested in static torsion.
- Dynamic compression performance (in accordance with ASTM)	The modified implants were compared with predicate devices that were previously tested in dynamic compression.
No significant differences that would adversely affect use	There are no significant differences between the Range Spinal System and other systems currently being marketed which would adversely affect the use of the product.
Substantially equivalent in design, function, material, and intended use	"It is substantially equivalent to these other devices in design, function, material and intended use."

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

Sample Size: Not explicitly stated. The text refers to "modified implants" and "predicate devices" but does not quantify the number of implants or tests performed.
Data Provenance: Not explicitly stated, but the testing was conducted in accordance with ASTM standards, suggesting a controlled testing environment rather than patient data. It is neither retrospective nor prospective in the context of a human study.

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

This information is not applicable. This document describes physical testing of spinal implants, not a diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable as it pertains to expert review of diagnostic data, which is not relevant here.

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 not an AI-assisted diagnostic device, and no human reader studies are mentioned.

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

This information is not applicable. This document describes physical device testing, not an algorithm.

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

The "ground truth" in this context is the performance of the predicate devices as established through prior testing (static and dynamic compression, static torsion per ASTM). The modified implants' performance in these same physical tests serves as the comparison to demonstrate substantial equivalence.

8. The sample size for the training set

This information is not applicable. There is no training set as this is not a machine learning or AI device.

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

This information is not applicable. There is no training set. The "ground truth" for the comparison was established by the previously validated performance of the predicate devices.

Summary of the Study:

The study proving the device meets its acceptance criteria is a mechanical performance study. The "modified implants" of the Range Spinal System were subjected to physical tests:

Static compression
Static torsion
Dynamic compression

These tests were performed in accordance with ASTM standards. The results of these tests were then compared directly to the performance of predicate devices that had undergone the same battery of tests previously. The conclusion was that the modified implants were "substantially equivalent" to the predicate devices in these mechanical performance aspects, as well as in design, function, material, and intended use. This substantial equivalence determination allowed the device to proceed to market.

Summary

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K123412-Page 1 of 2

FEB 1 3 2013

510(k) Summary for the Range Spinal System: Small Stature, Additional Components

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

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

Date Prepared: 11/05/12

Tradename: Common Name: Classification Name:

Device Product Code: Regulatory Class:

Range Spinal System Spinal Fixation System Pedicle Screw Spinal System (21CFR 888.3070) Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) MNI, KWP, MNH, OSH Class II

3. Predicate or legally marketed devices which are substantially equivalent:

K2M Range Spinal System (K070229, K120099, K121630) ●

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 Cobalt Chrome per ASTM and ISO standards.

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

The purpose of this submission is to add modified Small Stature components (screws, hooks and connectors) to the system.

5. Intended Use:

RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

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K123412—Page 2 of 2

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.

7. Comparison of the performance data of the device to predicate and legally marketed devices : The modified implants were compared with predicate devices that were previously tested in static compression, static torsion and dynamic compression in accordance with ASTM. The modified implants were determined to be substantially equivalent to the predicate devices.

8. Conclusion :

There are no significant differences between the Range Spinal System and other 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

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

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

FEB 1 3 2013

Re: K123412

Trade/Device Name: Range Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, MNH, MNI, KWP Dated: January 16, 2013 Received: January 24, 2013

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:

"The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels."

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Christy Foreman

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123412

Device Name: Range Spinal System

Indications for Use:

RANGE /DENALI, MESA and SMALL STATURE and ARI 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. 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-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 fusion, in skeletally mature patients, 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System.is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

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)

Ronald-P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Summary: K123412

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.