When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods: The hooks and rods are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors: The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors: The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw System is 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, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Device Description

The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links). These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only. The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from Zimmer Spine, Inc. to the FDA. The purpose of this submission is not to introduce a new device or a new algorithm, but rather to update the product-specific package inserts (IFU) with MRI Conditional language only for existing pedicle screw-rod systems. Therefore, the traditional acceptance criteria and study design for a new medical device would not apply in the same way.

The "study" conducted here is a series of performance tests to demonstrate the MRI compatibility of the existing devices.

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

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

Acceptance Criteria (Implied for MRI Conditional Labeling)	Reported Device Performance (Summary of Testing)
Device does not experience unsafe displacement near the MRI scanner. (Assessed by ASTM F2052)	Screws and rods were assessed per ASTM F2052. (Details of actual displacement values not provided in this summary).
Device does not produce unacceptable image artifacts during MRI. (Assessed by ASTM F2119)	Screws and rods were assessed per ASTM F2119. (Details of artifact size/severity not provided in this summary).
Device does not experience unsafe radiofrequency (RF) induced heating during MRI. (Assessed by ASTM F2182)	Screws and rods were assessed per ASTM F2182. (Details of actual temperature rise not provided in this summary).
Device does not experience unsafe torque near the MRI scanner. (Assessed by ASTM F2213)	Screws and rods were assessed per ASTM F2213. (Details of actual torque values not provided in this summary).
Device remains substantially equivalent to predicate devices regarding safety and effectiveness with updated MRI labeling.	"Zimmer Spine considers the subject Zimmer Spine Pedicle Screw-Rod Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Pedicle Screw-Rod Systems..." based on performance testing and no changes to other critical aspects.

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

Sample Size: The document does not specify the exact number of individual screws and rods tested from each system. It states "Magnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately." This implies representative samples of the various components were used.
Data Provenance: The testing was likely conducted in a controlled laboratory environment by Zimmer Spine or a contracted test facility in the USA (given the submitter's location in Minneapolis, Minnesota, USA, and submission to the FDA). The tests themselves are prospective in nature, as they involve actively conducting measurements on physical devices.

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 is not applicable to this submission. The "ground truth" in this context is established by adherence to recognized ASTM standards for MRI compatibility testing, which are objective, quantifiable measurements. There is no subjective expert interpretation of output data in the same way there would be for image analysis or clinical diagnosis.

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

Not applicable. This type of testing involves objective physical measurements according to standardized protocols, not subjective expert review or adjudication.

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 submission is for MRI compatibility of hardware (pedicle screw-rod systems), not an AI device or a diagnostic tool that involves human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this performance testing is defined by the objective pass/fail criteria established within the referenced ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213). These standards provide quantitative thresholds for magnetic field interactions (displacement, torque, heating) and qualitative assessments of image artifact.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable.

Summary

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

June 18, 2015

Zimmer Spine, Incorporated Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K142752

Trade/Device Name: Minit® Posterior Cervical-Thoracic Fixation System, Nex-Link® Spinal Fixation System, Nex-Link OCT® Cervical Plating System, Sequoia® Pedicle Screw System including SpeedLink IITM, ST360® Spinal Fixation System, and Title® 2 Polyaxial Spinal System

Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH Dated: May 18, 2015 Received: May 19, 2015

Dear Ms. Semlak:

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

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

Page 2 - Ms. Donna M. Semlak

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

If vou 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/Resourcesfor You/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 yours,

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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510(k) Number (if known) K142752

Device Name

Minit(R) Posterior Cervical-Thoracic Fixation System

Indications for Use (Describe)

Hooks and Rods

The hooks and rods are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors

The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

510(k) Number (if known) K142752

Device Name Nex-Link(R) Spinal Fixation System

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

510(k) Number (if known) K142752

Device Name

Nex-Link OCT(R) Cervical Plating System

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K142752

Device Name

Sequoia(R) Pedicle Screw System including SpeedLink II(TM)

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

510(k) Number (if known) K142752

Device Name ST360°(R) Spinal Fixation System

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

510(k) Number (if known) K142752

Device Name Title(R) 2 Polyaxial Spinal System

Indications for Use (Describe)

The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image contains the logo for Zimmer Spine. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, with the word "spine" underlined and in a smaller font size.

510(k) SUMMARY

Pedicle Screw-Rod Systems

Date of Summary Preparation:	May 18, 2015
Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439USA
Establishment RegistrationNumber:	2184052 (Minneapolis)
Company Contact (Primary):	Donna M. SemlakSenior Regulatory Affairs SpecialistEmail: Donna.Semlak@zimmer.comOffice: 952.857.5643Email Fax: 952.857.5843
Common Name(s):	Pedicle Screw-Rod Systems
Device/Trade Names(s):	Minit ® Posterior Cervical-Thoracic Fixation SystemNex-Link ® Spinal Fixation SystemNex-Link OCT ® Cervical Plating SystemSequoia ® Pedicle Screw System including SpeedLink II ™ST360 ® Spinal Fixation SystemTitle ® 2 Polyaxial Spinal System
Device Classification:	Class III / II
Regulation Number andProduct Code(s):	21 CFR § 888.3050 / KWPU/c@•ã, Fixation, Spinal Inter æ{ ã æ21 CFR § 888.3070 / MNI / MNHOrthosis, Spinal Pedicle Fixation21 CFR § 888.3070 / NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

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Predicate Devices:

The primary predicate device for this submission is the currently marketed Zimmer Spine ST360 Spinal Fixation System listed below. The purpose of this submission is to update product specific package inserts (IFU) with MRI Conditional language only.

Product Name	FDA 501(k) orPMA Numbers	Classification	Primary Code
ST360	K133291	Class III / II	NKB21 CFR § 888.3070

Additional Predicate Devices:

Product Name	FDA 501(k) Numbers	Classification	Primary Code
Minit	K070282	Class III / II	NKB21 CFR § 888.3070
Minit	K060683	Class II	KWP21 CFR § 888.3050
NexLink	K062505	Class II	MNI21 CFR § 888.3070
NexLink	K060634
NexLink	K052566
NexLink	K052247
NexLink	K031985
NexLink
NexLink OCT	K090060	Class II	KWP21 CFR § 888.3050
Sequoia(Speedlink)	K131980	Class III / II	NKB21 CFR § 888.3070
Title 2(Northstar)	K133086	Class III / II	NKB21 CFR § 888.3070

There are no reference devices for this submission.

General Device Description:

These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only

The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.

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System	Indications for Use
Minit® PosteriorCervical-ThoracicFixation System	When intended to promote fusion of the cervical spine and the thoracic spine, (CIT3), theEndius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for thefollowing: DDD (neck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation,failed previous fusion and/or tumors.
	Hooks and RodsThe hooks and rods are also intended to provide stabilization to promote fusionfollowing reduction of fracture/dislocation or trauma in the cervical/upper thoracic(C1-T3) spine.
	Screws/ConnectorsThe use of screws is limited to placement in the TI-T3 in treating thoracic conditions only.Screws are not intended to be placed in the cervical spine.
	Axial and Offset Rod ConnectorsThe Minit Posterior Cervical and Upper Thoracic Fixation System can also belinked to the TiTLE and TiTLE 2 System offered by Endius Inc. using the AxialRod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Nex-Link® SpinalFixation System	When intended to promote fusion of the cervical spine and the thoracic spine, (C I-T3), theNexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenicorigin with degeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
	Hooks and rods are also intended to provide stabilization to promote fusion followingreduction of fracture/dislocation or trauma in the cervical/upper thoracic (C I-T3) spine.
	The use of multiaxial screws is limited to placement in T I-T3 in treating thoracic conditionsonly. The multiaxial screws are not intended to be placed in the cervical spine.
Nex-LinkOCT®CervicalPlating System	The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization asan adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3)for the following indications: degenerative disc disease (neck pain of discogenic origin withdegeneration of the disk as confirmed by patient history and radiological studies),spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability,occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
	The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mmthreaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allowfor occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side LoadingClosed Screws are limited to placement in the upper thoracic spine (T1-T3) for additionalstabilization of the cervical spine for the indications specified above.
Sequoia® PedicleScrewSystemincludingSpeedLink II™	When intended for pedicle screw fixation from T1 –S1, the Sequoia Pedicle Screw System isintended to provide immobilization and stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of the following acute and chronicinstabilities or deformities of the thoracic, lumbar and sacral spine: degenerative discdisease (defined as discogenic back pain with degeneration of the disc confirmed by historyand radiographic studies), degenerative spondylolisthesis with objective evidence ofneurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis,kyphosis, and/or lordosis), tumor and failed previous fusion.
	As pedicle screw system places between L3 and S1, the indications include Grade 3 orGrade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to theposterior lumbosacral spine, and intended to be removed after the solid fusion isestablished.
	When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1),the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis withassociated paralysis or spasticity, scoliosis with deficient posterior elements such as thatresulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or latedeformity), degenerative disc disease (back pain of discogenic origin with degenerative ofthe disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinalstenosis and failed previous fusion.
System	Indications for Use
	After solid fusion occurs, these devices serve no functional purpose and should be removed.In most cases, removal is indicated because the implants are not intended to transfer orsupport forces developed during normal activities. Any decision to remove the device mustbe made by the physician and the patient, taking into consideration the patient's generalmedical condition and the potential risk to the patient of a second surgical procedure.
ST360°® SpinalFixation System	The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined asback pain of discogenic origin with degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis,and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
	When used as a sacral screw system, the ST360° Spinal Fixation System is intended foruse in the treatment of degenerative disc disease (as defined as chronic back pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographicstudies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine,loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation,pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws ofthe ST360° Spinal Fixation System are intended for the sacral iliac attachment only.Transverse connectors of the system are intended for posterior thoracic and/or lumbar useonly. As a whole, the levels of use for sacral screw fixation of this system are T1 to thesacrum.
Title® 2 PolyaxialSpinal System	The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed by history and radiographicstudies). Levels of fixation are for the thoracic, lumbar and sacral spine.
	The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provideimmobilization and stabilization of spinal segments in skeletally mature patients as anadjunct to fusion in the treatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis withobjective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinaltumor, and failed previous fusion (pseudoarthrosis).
	The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severespondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenousbone graft is used, when affixed to the posterior lumbosacral spine, and intended to beremoved after solid fusion is attained. Levels of fixation are from L3-S1.
	In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, isindicated for sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screwindications are spondylolisthesis, degenerative disc disease, (defined as discogenic backpain with degeneration of the disc confirmed by history and radiographic studies),deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusionsurgery.
	The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical andUpper Thoracic Fixation System.

{11}------------------------------------------------

Summary of Technological Characteristics:

The technological characteristics remain the same between the subject and predicate devices. There are no changes to the implants (rods and/or screws) and instrumentation within this submission. This submission is only proposing labeling updates regarding interactions with magnetic fields during Magnetic Resonance Imaging (MRI) with respect to patient safety.

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Summary of Performance Testing:

Maqnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately to design controls and the following ASTM Standards.

ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically ● Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts ● from Passive Implants
ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency ● Induced Heating Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically ● Induced Torque on Medical Devices in the Magnetic Resonance Environment

Conclusion:

Zimmer Spine considers the subject Zimmer Spine Pedicle Screw-Rod Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Pedicle Screw-Rod Systems listed as above because:

No changes to the intended use,
No changes to mechanical and functional performance. ●
No changes to the functional scientific technology, ●
No changes to the implants (screws or rods), ●
No changes to the instrumentation, ●
No changes to the technological characteristics mentioned above ●
No changes to the surgical technique steps ●

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.