K Number

Device Name

Manufacturer

GLOBUS MEDICAL INC.

Date Cleared

2006-07-20

(80 days)

Product Code

NKB,KWP,KWQ,MNH,MNI

Regulation Number

888.3070

Type

Special

Panel

Orthopedic

Reference & Predicate Devices

K040442,K052069,K012870,K031090,K053115

Intended Use

The REVERE™ Stabilization System, when used as posterior pedicle screw systems, are 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE™ Stabilization Systems are 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 as posterior non-pedicle screw fixation systems, the REVERE™ Stabilization Systems are intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as anterolateral thoracolumbar systems, the REVERE™ Stabilization Systems are intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Device Description

The REVERE™ Stabilization Systems consist of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138.

AI/ML Overview

The REVERE™ Stabilization System did not provide a typical "acceptance criteria" table as one might find for a diagnostic device. The provided document is a 510(k) summary for a medical device (spinal stabilization system), and regulatory submissions for such devices typically focus on demonstrating substantial equivalence to a legally marketed predicate device through mechanical testing, rather than reporting performance against a set of predefined clinical accuracy metrics.

Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the mechanical testing standards for spinal systems. The "reported device performance" refers to the fact that the REVERE™ system met these implied criteria through its mechanical testing.

Here's the breakdown based on the provided text, and where information is not explicitly stated in the context of typical AI/diagnostic device studies, it will be noted as "Not applicable" or "Not specified."

Acceptance Criteria and Device Performance for REVERE™ Stabilization System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance Standards: Device must comply with the mechanical testing requirements outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004.	Meets Guidance: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates the device successfully underwent and met the specified mechanical testing standards.
Substantial Equivalence: Device must demonstrate substantial equivalence to legally marketed predicate devices (PROTEX™ Stabilization System and Stryker XIA Stainless Steel System) with respect to technical characteristics, performance, and intended use.	Demonstrates Equivalence: "The REVERE™ Stabilization System implants are similar to the predicate PROTEX™ (K040442, K052069) and Stryker Xia (K012870, K031090, K053115) thoracolumbar stabilization system with respect to technical characteristics, performance, and intended use." The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..."

Acceptance Criteria (Implied)

Reported Device Performance

Mechanical Performance Standards: Device must comply with the mechanical testing requirements outlined in the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004.

Meets Guidance: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates the device successfully underwent and met the specified mechanical testing standards.

Substantial Equivalence: Device must demonstrate substantial equivalence to legally marketed predicate devices (PROTEX™ Stabilization System and Stryker XIA Stainless Steel System) with respect to technical characteristics, performance, and intended use.

Demonstrates Equivalence: "The REVERE™ Stabilization System implants are similar to the predicate PROTEX™ (K040442, K052069) and Stryker Xia (K012870, K031090, K053115) thoracolumbar stabilization system with respect to technical characteristics, performance, and intended use." The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..."

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

Sample Size for Test Set: Not applicable. For a spinal stabilization system, "test sets" in the context of diagnostic AI algorithms are not relevant. The device undergoes mechanical testing based on specified standards, which involves a specific number of devices/components tested under simulated physiological conditions. The document does not specify the number of units tested in the mechanical assessment but references the governing guidance document.
Data Provenance: Not applicable in the context of clinical patient data. The "data" here refers to the results of mechanical testing performed on the device components. The location of these tests is not specified in the summary but would typically occur in a controlled laboratory environment.

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

Not applicable. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for mechanical testing is established by engineering standards and validated testing methodologies.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human experts in interpreting diagnostic data. This is not relevant for mechanical testing.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore MRMC studies comparing human readers with and without AI assistance are not relevant.

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

Not applicable. This is a physical medical implant, not a software algorithm.

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

The "ground truth" for this device's performance is established by engineering standards and validated mechanical testing protocols. This involves evaluating the strength, fatigue resistance, and other mechanical properties of the device components under various loads as defined by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s."

8. The sample size for the training set

Not applicable. The concept of a "training set" is for machine learning models. For a physical device, the "training" involves engineering design, material selection, and manufacturing processes, with iterative testing. The document does not provide a "sample size" for this developmental stage.

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

Not applicable. As above, this concept refers to machine learning. The "ground truth" for design and development in medical device manufacturing is based on established biomechanical principles, material science, and prior knowledge from existing predicate devices. Successful mechanical testing (as mentioned in section 7) confirms that the design meets the required performance standards.

Summary

{0}------------------------------------------------

510(k) - REVERE TMSystem

K061202

. 510(K) Summary

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker

JUL 2 0 2006

DEVICE NAME:

REVERE™ Stabilization System

CLASSIFICATION:

Per 21 CFR as follows: §888.3050 Spinal Interlaminal Fixation Orthosis §888.3060 Spinal Intervertebal Body Fixation Orthosis §888.3070 Pedicle Screw Spinal System §888.3070 Spondylolisthesis Spinal Fixation Device System Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class II and III. Panel code 87.

PREDICATE DEVICES:

Globus Medical PROTEX Stabilization System: PROTEX K040442, SE date May 20, 2004 PROTEX 6.0mm rods, K052069, SE date August 17, 2005 Stryker XIA Stainless Steel System K012870, SE date September 24, 2001 Line extensions K031090, SE date April 24, 2003 Line extensions K053115, SE date December 6, 2005 Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class II and III.

DEVICE DESCRIPTION:

{1}------------------------------------------------

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The REVERE™ Stabilization System implants are similar to the predicate PROTEX™ (K040442, K052069) and Stryker Xia (K012870, K031090, K053115) thoracolumbar stabilization system with respect to technical characteristics, performance, and intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2006

Globus Medical, Inc. % Ms. Kelly Baker Director, Regulatory and Clinical Affairs 303 Schell Lane Phoenixville, Pennsylvania 19460

Re: K061202

Trade/Device Name: REVERE™ Stabilization System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: June 20, 2006 Received: June 21, 2006

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2- Ms. Kelly Baker

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbare Pruchus

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement ll.

510(k) Number:

REVERE™ Stabilization System Device Name:

Indications:

The REVERE™ Stabilization System, when used as a posterior pedicle screw The REVERE - Otablication of stabilization and stabilization of spinal segments in system, is intonood to pro no adjunct to fusion in the treatment of the following skeretaily mature patients or deformities of the thoracic, lumbar and sacral spine: acute and onlorno motions includes discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis diso connifica by motory and rologic impairment, fracture, dislocation, scoliosis, with objootive only of hemor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE™ System is intended for treatment of severe in addition, the REG (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature spondylolistics (Graces o artogenous bone graft, having implants attached to the patiente rooorning fablo ilium with removal of the implants after attainment of a furniousation. Levels of pedicle screw fixation for these patients are L3-sacrum/lilium.

When used as a posterior non-pedicle screw fixation system, the REVERE™ Which used as a poctorior now d for the treatment of degenerative disc disease Stablinzation Bystem is intondou for the disc confirmed by history (defined as aloogents baon phal stenosis, spondylolisthesis, spinal deformities (i.e. and radiographis sand/or lordosis, Scheuermann's disease), fracture, sconosis, typhodio, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE™ Stabilization When used as an anterolateral screw (with or without staple) fixation for the System is intended for antorolation on on one in the manage (defined as discogenic back pain following muleations: usgonerative med by history and radiographic studies), spinal whan degonoration or thesis, spinal deformities (i.e. scoliosis, kyphosis, and/or Sterlosis, Sportuyionstrions, Spinal the thoracolumbar spine, pseudoarthrosis, tumor fordosis); frusture of ed previous fusion. Levels of screw fixation are T8-L5.

Prescription Use __ × (Per 21 CFR §801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Barbar
(Division Sign-Onurnencebe Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,

and Neurological Devices

510(k) Number K

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.