The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO® Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

Device Description

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition

CREO® implants are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138. Rods are also available in commercially pure titanium, as specified in ASTM F67. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185.

Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromiummolybdenum alloy implants.

AI/ML Overview

This document is a 510(k) premarket notification for the CREO® Stabilization System. It details the device's indications for use, its description, and the basis for its substantial equivalence to previously cleared devices. The document highlights mechanical testing conducted to demonstrate this equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in a table format. However, it does state that mechanical testing was conducted to demonstrate substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Device performance is substantially equivalent to predicate devices for mechanical properties.	Mechanical testing (static and dynamic compression and static torsion) was conducted in accordance with ASTM F1717 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004.
Device is sterile and biocompatible.	Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Previous sterilization and biocompatibility testing applies to the subject devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "mechanical testing (static and dynamic compression and static torsion) was conducted."

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 type of information is not applicable to this submission. The "ground truth" concept is typically relevant for studies evaluating diagnostic or AI-based devices where human expert consensus is used to label data. This document describes a medical device (spinal fixation system) cleared based on mechanical performance and substantial equivalence, not a diagnostic or AI device.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are used in studies involving human interpretation or labeling of data, which is not the primary method for evaluating this type of medical device for 510(k) clearance.

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 type of study is not applicable. An MRMC study evaluates the performance of human readers, typically in the context of diagnostic imaging, with and without AI assistance. This document pertains to a spinal fixation system and its mechanical and material properties, not an AI-based diagnostic tool.

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

This information is not applicable as this is not an AI algorithm. The device is a physical medical implant.

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

The "ground truth" in this context is the established performance standards and material properties defined by ASTM and FDA guidance documents for spinal systems. The device's performance is compared against these engineering and material specifications.

8. The sample size for the training set

This information is not applicable as this is not an AI algorithm that undergoes training.

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

This information is not applicable as this is not an AI algorithm that undergoes training.

Summary

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April 2, 2018

Globus Medical Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K180210

Trade/Device Name: CREO® Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: January 23, 2018 Received: January 24, 2018

Dear Dr. Baker:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180210

Device Name CREO® Stabilization System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary: CREO® Stabilization System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
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Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
April 2, 2018 Date Prepared:

Device Name: CREO® Stabilization System

Classification: Per 21 CFR as follows: §888.3070 Thoracolumbosacral pedicle screw system §888.3060 Spinal intervertebral body fixation orthosis §888.3050 Spinal interlaminal fixation orthosis Product Codes NKB, KWQ, KWQ, KWP Requlatory Class: II, Panel Code: 87
Primary Predicate: CREO® Stabilization System (K124058 & K143633)

Additional	Synthes USS System (K170654)
Predicates:	REVERE Stabilization System (K061202, K091782, K122226)
	REVERE 4.5 Stabilization System (K113395)

Reference

Devices: QUARTEX Occipito-Cervico-Thoracic Spinal System (K161591)

Purpose:

The purpose of this submission is to request clearance for additional CREO® implants.

Device Description:

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Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromiummolybdenum alloy implants.

Indications for Use:

The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

Performance Data:

Mechanical testing (static and dynamic compression and static torsion) was conducted in accordance with ASTM F1717 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004 to demonstrate

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substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

No further sterilization or biocompatibility evaluation and/or testing were required for this submission. Previous sterilization and biocompatibility testing applies to the subject devices.

Technological Characteristics:

Subject CREO® implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Basis of Substantial Equivalence:

Subject CREO® implants are similar to the predicate device with respect to technical characteristics, performance, design, and intended use. The information provided within this premarket notification supports substantial equivalence 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.