When used as a vertebral body replacement device, the InFix System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectorny procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix intended to be used with bone graft.

When used as an intervertebral body fusion device, the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation.

For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non- operative treatment.

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone.

The BAK device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels(s). BAK devices are to be implanted via an open anterior or posterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach.

All BAK devices are also indicated for lapantation at the L4-L5 and L5-S1 levels for the same clinical indications described above.

Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3-LS) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebres) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graff.

Device Description

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems are intended for use in the cervical, thoracic and/or lumbar spine to mitigate and/or replace the disc space. The interbody fusion devices are intended for use with autogenous bone graft in patient with degenerative disc disease (DDD); defined as discogenic back pain and degeneration of the disc space. The vertebral body replacement (VBR) devices are intended to replace a collapsed, damaged or unstable vertebral body. VBR devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column in the absence of fusion for a prolonged period.

The subject devices are to be implanted by either an anterior approach or a posterior approach or a transforaminal approach per the indications for use and/or the instructions of the surgical technique quide(s). The BAK devices are also indicated for laparoscopic implantation, per the device indications for use.

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device System implants are manufactured from medical grade Ti-6AI-4V ELI titanium alloy or Polyether ether ketone (PEEK) OPTIMA with tantalum markers. The InFix system allows for the use of an optional Endcap made from Ultra High Molecular Weight Polyethylene (UHMWPE).

System(s) with instrumentation, the instruments are manufactured from one (or more) of the following materials: Surgical Grade Stainless Steel, Aluminum, Silicone Rubber, Radel, AITiN PVD coating, TiN PVD Coating, Nylon.

The subject implants are provided terminally sterilized with the exception of the InFix System, which is provided Non-Sterile. The InFix System must be sterilized by the end-user/healthcare facility prior to use. The subject implants are designed for single-use only. The System(s) instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use.

AI/ML Overview

This document is a 510(k) premarket notification for several spinal implant devices, primarily focused on updating product specific package inserts with MRI Conditional language. Therefore, the "acceptance criteria" and "device performance" discussed relate to MRI compatibility, rather than clinical efficacy or diagnostic accuracy.

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

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

Acceptance Criteria (related to MRI Compatibility)	Reported Device Performance
The devices were tested against established ASTM standards for MRI compatibility to determine if they meet the criteria for "MRI Conditional" labeling. This implies meeting thresholds for: - Magnetically Induced Displacement Force (ASTM F2052) - MR Image Artifacts (ASTM F2119) - Radio Frequency Induced Heating Near Passive Implants (ASTM F2182) - Magnetically Induced Torque (ASTM F2213) While specific numerical acceptance criteria are not explicitly stated in this document (e.g., maximum displacement, artifact size limits, temperature rise limits), the implication is that the devices passed these tests to qualify for MRI Conditional labeling. The underlying acceptance would be that the forces, heating, and artifacts generated during an MRI scan at specified field strengths would not pose an unacceptable risk to the patient and would allow for diagnostically acceptable imaging if properly managed according to the labeling.	Summary of Performance Testing: Magnetic Resonance Imaging (MRI) testing of interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device 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 The document asserts that these tests were conducted to support the update of product-specific package inserts (IFU) with MRI Conditional language. This indicates that the devices performed within the acceptable limits of these standards to be deemed "MRI Conditional."

Acceptance Criteria (related to MRI Compatibility)

Reported Device Performance

The devices were tested against established ASTM standards for MRI compatibility to determine if they meet the criteria for "MRI Conditional" labeling. This implies meeting thresholds for: - Magnetically Induced Displacement Force (ASTM F2052) - MR Image Artifacts (ASTM F2119) - Radio Frequency Induced Heating Near Passive Implants (ASTM F2182) - Magnetically Induced Torque (ASTM F2213) While specific numerical acceptance criteria are not explicitly stated in this document (e.g., maximum displacement, artifact size limits, temperature rise limits), the implication is that the devices passed these tests to qualify for MRI Conditional labeling. The underlying acceptance would be that the forces, heating, and artifacts generated during an MRI scan at specified field strengths would not pose an unacceptable risk to the patient and would allow for diagnostically acceptable imaging if properly managed according to the labeling.

Summary of Performance Testing: Magnetic Resonance Imaging (MRI) testing of interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device 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 The document asserts that these tests were conducted to support the update of product-specific package inserts (IFU) with MRI Conditional language. This indicates that the devices performed within the acceptable limits of these standards to be deemed "MRI Conditional."

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 MRI compatibility tests. It refers to "interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems," implying that representative samples of the various devices (Ardis, BAK, InFix, TraXis, etc.) were tested.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as this type of testing is typically controlled laboratory testing of the devices themselves, not patient data.

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 the performance testing described. MRI compatibility testing involves standardized physical measurements in a laboratory setting, not expert interpretation of clinical data to establish a "ground truth."

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

Not applicable. This testing is based on objective physical measurements according to ASTM standards, not subjective assessments requiring 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 document is a 510(k) submission for spinal implants, specifically addressing MRI compatibility, not an AI-based diagnostic tool.

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

Not applicable. This document does not describe an algorithm or AI.

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

Not applicable. For MRI compatibility testing, the "ground truth" is adherence to the physical and safety limits defined by the ASTM standards and regulatory requirements for MRI Conditional labeling.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

February 12, 2015

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

Re: K143297

Trade/Device Name: InFix® Anterior Lumbar System, Ardis® Interbody System, BAK® Interbody Fusion System, BAK/C® Anterior Cervical Interbody Fusion System, TraXis® Vertebral Body Replacement (Ti and VUE) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: November 14, 2014 Received: November 17, 2014

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 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

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Page 2 - Ms. Donna M. Semlak

(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 (OS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

K143297 Page 1 of 5

Device Name InFix® Anterior Lumbar System

Indications for Use (Describe)

For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K143297

K143297

Device Name Ardis® Interbody System

Indications for Use (Describe)

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Indications for Use

510(k) Number (if known) K143297

Device Name

BAK /C® Anterior Cervical Interbody Fusion 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

K143297 Page 3 of 5

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Indications for Use

510(k) Number (if known) K143297

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

K143297

Page 4 of 5

Device Name BAK® Interbody Fusion System

Indications for Use (Describe)

Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach.

All BAK devices are also indicated for lapantation at the L4-L5 and L5-S1 levels for the same clinical indications described above.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Indications for Use

510(k) Number (if known) K143297

Device Name

TraXis® Vertebral Body Replacement (Ti and VUE)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

K143297 Page 5 of 5

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Image /page/7/Picture/1 description: The image shows 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 blue, with the word "spine" written in a smaller font size below a horizontal line.

510(k) SUMMARY

Interbody Fusion and Vertebral Body Replacement (VBR) Devices

Date of Summary Preparation:	February 11, 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):	Interbody Fusion SystemsVertebral Body Replacement Systems
Device/Trade Names(s):	Ardis® Interbody SystemBAK® Interbody Fusion SystemBAK/C® Anterior Cervical Interbody Fusion SystemInFix® Anterior Lumbar SystemTraXis® Vertebral Body Replacement (TraXis Ti, TraXis VUE)
Device Classification:	Class II
Requlation Number andProduct Code(s):	21 CFR § 888.3080 / MAXIntervertebral Fusion Device with Bone Graft, Lumbar21 CFR § 888.3060 / MQPSpinal Vertebral Body Replacement Device

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The primary predicate device for this submission is the currently marketed Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems 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
InFix Anterior LumbarSystem	K132790	Class II	MAX21 CFR § 888.3080MQP21 CFR § 888.3060

Additional Predicate Devices:

Product Name	FDA 501(k) orPMA Numbers	Classification	Primary Code
Ardis Interbody	K133184	Class II	MAX21 CFR § 888.3080
BAK Interbody	P950002	Class IIRe-classified 2007	MAX21 CFR § 888.3080
BAK Proximity	P950002	Class IIRe-classified 2007	MAX21 CFR § 888.3080
BAK / C Interbody	P980048	Class IIRe-classified 2007	MAX21 CFR § 888.3080
InFix	K031672	Class II	MQP21 CFR § 888.3060
TraXis Ti	K033517	Class II	MQP21 CFR § 888.3060
TraXis VUE	K033517	Class II	MQP21 CFR § 888.3060
Zimmer TMT VBR-L	K070754	Class II	MQP21 CFR § 888.3060
Zimmer TMT TM Ardis	K113561	Class II	MAX21 CFR § 888.3080
Zimmer TMT Vista-S	K133784, K111983	Class II	ODP21 CFR § 888.3060
Zimmer TMT TM-400*	K120203	Class II	MAX21 CFR § 888.3080MQP21 CFR § 888.3060

*FDA clearance for MRI Labeling

General Device Description:

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Product Name	Indications For Use
Ardis InterbodySystem	The Ardis Interbody System is indicated for use withautogenous bone graft as an intervertebral body fusiondevice at one or two contiguous levels in the lumbosacralregion (L2-S1) in the treatment of degenerative disc disease(DDD) with up to Grade 1 spondylolisthesis or retrolisthesisat the involved level(s). DDD is defined as discogenic backpain with degeneration of the disc confirmed by history andradiographic studies. Patients with previous non-fusion spinalsurgery at involved level may be treated with the device.Patients should be skeletally mature and have had sixmonths of non- operative treatment.The Ardis Interbody System is implanted using a posterior ortransforaminal approach and is intended to be used singly orin pairs with supplemental fixation.
BAK InterbodyFusion System	The BAK device is indicated for use with autogenous bonegraft in patients with degenerative disc disease (DDD) at oneor two contiguous levels form L2-S1. These DDD patientsmay also have up to Grade I spondylolisthesis orretrolisthesis at the involved levels(s). BAK devices are to beimplanted via an open anterior or posterior approach. DDD isdefined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies. Thesepatients should be skeletally mature and have had sixmonths of non-operative treatment.
Product Name	Indications For Use
	Standard BAK devices and BAK/Proximity devices are to beimplanted via an open anterior or posterior approach.BP/Lordotic devices are to be implanted via an open anteriorapproach.
	All BAK devices are also indicated for laparoscopicimplantation at the L4-L5 and L5-S1 levels for the sameclinical indications described above.
BAK / C AnteriorCervical InterbodyFusion System	The BAK/C implant is indicated for use in skeletally maturepatients with degenerative disc disease (DDD) of the cervicalspine with accompanying radicular symptoms at one disclevel. DDD is defined as discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies.BAK/C implants are used to facilitate fusion in the cervicalspine and are placed via an anterior approach at the C-3 toC-7 disc levels using autograft bone.
	When used as a vertebral body replacement device, the InFixSystem is intended for use in the thoracic and/or lumbarspine (T3-L5) to replace a collapsed, damaged or unstablevertebral body resected or excised (i.e., partial or totalvertebrectomy procedures) due to tumor or trauma (i.e.,fracture). The InFix System is designed to restore thebiomechanical integrity of the anterior, middle and posteriorspinal column even in the absence of fusion for a prolongedperiod. The InFix implant is intended to be used with bonegraft.
InFix AnteriorLumbar System	When used as an intervertebral body fusion device, the InFixSystem is indicated for use with autogenous bone graft atone or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) withup to Grade 1 spondylolisthesis or retrolisthesis at theinvolved level(s). DDD is defined as discogenic back painwith degeneration of the disc confirmed by history andradiographic studies. Patients with previous non-fusion spinalsurgery at involved level may be treated with the device.Patients should be skeletally mature and have had sixmonths of non-operative treatment. When used as anintervertebral body fusion device, the InFix implant isintended to be used with supplemental fixation.
	For both of the indications listed above, the InFix implant isintended to be implanted via an open anterior approach.
TraXis VertebralBody Replacement	Cadence and TraXis are vertebral body replacement devicesthat are intended for use in the thoracic and/or thoracolumbarspine (T3-L5) to replace a collapsed, damaged or unstablevertebral body resected or excised (i.e., partial or totalvertebrectomy procedures) due to tumor or trauma (i.e.,fracture). These devices are designed to restore thebiomechanical integrity of the anterior, middle and posteriorspinal column even in the absence of fusion for a prolongedperiod. These devices are intended to be used with bonegraft.

Indications for Use:

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Summary of Technological Characteristics:

The technological characteristics remain the same between the subject Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems as the predicate devices listed above. There are no changes to the implants (interbody and VBR) 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.

All the technology characteristics remain the same: same system's intended use. same mechanical and functional scientific technology; same materials and the same substantially equivalent performance characteristics.

Summary of Performance Testing:

Magnetic Resonance Imaging (MRI) testing of interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device 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

Zimmer Spine considers the subject Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device 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

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.