The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, traumatic kyphosis or lordosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.

The PULSE Anterior Cervical Plate System is indication of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

Device Description

The SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system.

The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.

The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.

The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.

The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.

The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.

The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the medical devices, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from referenced standards)	Reported Device Performance
MR Safety: Heating	Defined by ASTM F2182-11a: "Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging"	Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling.
MR Safety: Torque	Defined by ASTM F2213-06: "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"	Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling.
MR Safety: Displacement	Defined by ASTM F2052-15: "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"	Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling.
MR Safety: Image Artifacts	Defined by ASTM F2119-07: "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"	Not explicitly detailed, but stated that testing was conducted and results supported MR conditional labeling.

Study Details for Device Acceptance:

This submission is for MR Conditional Labeling for existing devices. The primary purpose is to demonstrate that the devices are safe for use in an MRI environment under specific conditions.

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

Sample Size: The document does not specify the exact number of devices or components tested. It generally refers to "tests and analyses were conducted."
Data Provenance: The data is from non-clinical testing (bench testing) performed by the manufacturer (Medos International, SARL). The location of the testing is not explicitly stated, but the manufacturer is based in Switzerland. This is prospective testing, specifically conducted to support the MR conditional claim.

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

Number of Experts: Not applicable. The ground truth for MR compatibility is established by adherence to recognized international standards (ASTM).
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The assessment relies on objective measurements against the criteria defined by the ASTM standards, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This submission does not involve a multi-reader multi-case comparative effectiveness study. It is focused on the inherent MR compatibility properties of the devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Yes, in a sense. The "performance" being evaluated is the physical interaction of the medical device with an MRI system. This is an objective measurement of the device's physical properties in an MRI environment, without human interpretation or intervention in the measurement process. The results directly reflect the device's inherent characteristics.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth is based on objective physical measurements and adherence to established international standards (ASTM) for MRI safety and compatibility. The FDA Guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, December 11, 2014" also serves as a guiding framework.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. These are physical medical devices, not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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July 20, 2017

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

Medos International SARL % Ms. Sheree Geller Regulatory Affairs Specialist DePuv Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K171439

Trade/Device Name: EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: May 15, 2017 Received: May 16, 2017

Dear Ms. Geller:

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.

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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) K171439

Device Name

EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLNE Anterior Cervical Plate System, SLM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System

Indications for Use (Describe)

The SLIM LOC Anterior Cervical Plate System and SK YLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intentnent range from C2 to T1.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
Manufacturer:	Medos International, SARLChemin-Blanc 382400 Le Locle, Switzerland
Contact Person:	Catherine KilshawSr. Regulatory Affairs Program LeadTelephone: (508) 880-8412Fax: (508) 828-3797
Date Prepared:	July 18, 2017
Trade Name:	SWIFT Plus Anterior Cervical Plate SystemEAGLE Plus Anterior Cervical Plate SystemEAGLE Plus Micro Anterior Cervical Plate SystemPULSE Anterior Cervical Plate SystemSKYLINE Anterior Cervical Plate SystemSLIM LOC Anterior Cervical Plate SystemUNIPLATE Anterior Cervical Plate SystemUNIPLATE 2 Anterior Cervical Plate System
Device Class:	II
Product Code:	KWQ
Common Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification Name:	Spinal intervertebral body fixation orthosis
Regulation Number:	21 CFR 888.3060
Predicate Devices:
EAGLE Plus Anterior Cervical Plates (K070994)
EAGLE Plus Micro Anterior Cervical Plate System (K080191)
PULSE Anterior Cervical Plate System (K112724)
SKYLINE Anterior Cervical Plate System (K052552, K103491)
SLIM LOC Anterior Cervical Plate System (K013877)
UNIPLATE Anterior Cervical Plate System (K042544)
UNIPLATE 2 Anterior Cervical Plate System (K082273, K100070)

DePuy Synthes Spine MR Compatibility Anterior Cervical Plates

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SWIFT Plus Anterior Cervical Plate System (K072546) Primary Predicate:

Additional

Submission Purpose: Obtain clearance for MR Conditional Labeling for the systems listed.

Device Descriptions:

SWIFT Plus	The SWIFT™ Plus Anterior Cervical Plate System is manufactured from titanium alloy and consists of segmented plates that allow up to 2mm of controlled graft settling between each of the segments. The plates are available with two to six screw hole pairs, in various lengths and two configurations, discectomy and corpectomy. The screws are available in various sizes and screw-tip geometries. A graft screw is available for use in the corpectomy plates and can be used in the SWIFT Plus system.
------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

SWIFT Plus

------------

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

EAGLE Plus The EAGLE™ Plus Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available with two to six screw hole pairs in various lengths. The screws are available in various sizes and screw-tip geometries.
EAGLE Micro The EAGLE Plus Micro Anterior Cervical Plate System is designed for use alone or adjacent to a previously implanted anterior cervical plate. The EAGLE Plus Micro Anterior Cervical Plate System consists of an assortment of titanium alloy single-level plates and uses EAGLE Plus screws. The anterior cervical plates are available in various lengths to accommodate varying patient anatomy.
PULSE The DePuy PULSE™ Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to four screw-hole pairs in various lengths. The screws are available in

{6}------------------------------------------------

various sizes and screw-tip geometries, including self drilling and blunt tip to create a semi-constrained construct.

SKYLINE The SKYLINE" Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths. The screws are available in various sizes and screwtip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
SLIM LOC The SLIM LOC® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates are available in lengths ranging from 22-111mm in configurations with 2, 3, 4, 5 or 6 pairs of screw holes. The SLIMLOC screws are available in 4.5mm in diameter and are available as self-drilling in even length sizes ranging from 10-18mm or self-tapping in even length sizes ranging from 10-26mm. Larger diameter screws (4.8mm) are available in 12, 14, and 16mm lengths.

UNIPLATE Anterior

UNIPLATE 2 The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to two segments of fixation. The screws are available in various sizes and tip geometries.

Indications: The SLIM LOC Anterior Cervical Plate System and SKYLINE Anterior Cervical Plate System are indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

{7}------------------------------------------------

Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems and the EAGLE Plus Micro Anterior Cervical Plate System are also indicated for treatment of spinal stenosis.

The PULSE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

Material: Implant Grade Titanium Alloy (ASTM F136)

Comparison to

Predicate Device: The subject devices maintain the design characteristics of the previously cleared predicate devices. The subject devices include a claim regarding MR compatibility.

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Non-clinical TestSummary:	Tests and analyses were conducted following standards referenced belowto support MR compatibility claims.
	ASTM 2182-11a, "Standard Test Method for Measurement of RadioFrequency Induced Heating On or Near Passive Implants During MagneticResonance Imaging"
	ASTM 2213-06, "Standard Test Method for Measurement of MagneticallyInduced Torque on Medical Devices in the Magnetic ResonanceEnvironment"
	ASTM 2052-15, "Standard Test Method for Measurement of MagneticallyInduced Displacement Force on Medical Devices in the MagneticResonance Environment"
	ASTM 2119-07, "Standard Test Method for Evaluation of MR ImageArtifacts from Passive Implants"
Clinical TestSummary:	N/A
Conclusion:	The proposed devices are identical to the predicate devices and thereforedetermined to be substantially equivalent. The devices are determinedto be MR conditional based on the results of testing completed accordingto FDA Guidance document "Establishing Safety and Compatibility ofPassive Implants in the Magnetic Resonance (MR) Environment",December 11, 2014.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.