Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) 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. 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 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. 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) 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. 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 {5}------------------------------------------------ # 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) 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. 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) 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. 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 {7}------------------------------------------------ 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.<br>7375 Bush Lake Road<br>Minneapolis, MN 55439<br>USA | | Establishment Registration<br>Number: | 2184052 (Minneapolis) | | Company Contact (Primary): | Donna M. Semlak<br>Senior Regulatory Affairs Specialist<br>Email: Donna.Semlak@zimmer.com<br>Office: 952.857.5643<br>Email Fax: 952.857.5843 | | Common Name(s): | Interbody Fusion Systems<br>Vertebral Body Replacement Systems | | Device/Trade Names(s): | Ardis® Interbody System<br>BAK® Interbody Fusion System<br>BAK/C® Anterior Cervical Interbody Fusion System<br>InFix® Anterior Lumbar System<br>TraXis® Vertebral Body Replacement (TraXis Ti, TraXis VUE) | | Device Classification: | Class II | | Requlation Number and<br>Product Code(s): | 21 CFR § 888.3080 / MAX<br>Intervertebral Fusion Device with Bone Graft, Lumbar<br>21 CFR § 888.3060 / MQP<br>Spinal Vertebral Body Replacement Device | {8}------------------------------------------------ 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) or<br>PMA Numbers | Classification | Primary Code | |---------------------------------|------------------------------|----------------|------------------------------------------------------| | InFix Anterior Lumbar<br>System | K132790 | Class II | MAX<br>21 CFR § 888.3080<br>MQP<br>21 CFR § 888.3060 | ### Additional Predicate Devices: | Product Name | FDA 501(k) or<br>PMA Numbers | Classification | Primary Code | |---------------------|------------------------------|--------------------------------|------------------------------------------------------| | Ardis Interbody | K133184 | Class II | MAX<br>21 CFR § 888.3080 | | BAK Interbody | P950002 | Class II<br>Re-classified 2007 | MAX<br>21 CFR § 888.3080 | | BAK Proximity | P950002 | Class II<br>Re-classified 2007 | MAX<br>21 CFR § 888.3080 | | BAK / C Interbody | P980048 | Class II<br>Re-classified 2007 | MAX<br>21 CFR § 888.3080 | | InFix | K031672 | Class II | MQP<br>21 CFR § 888.3060 | | TraXis Ti | K033517 | Class II | MQP<br>21 CFR § 888.3060 | | TraXis VUE | K033517 | Class II | MQP<br>21 CFR § 888.3060 | | Zimmer TMT VBR-L | K070754 | Class II | MQP<br>21 CFR § 888.3060 | | Zimmer TMT TM Ardis | K113561 | Class II | MAX<br>21 CFR § 888.3080 | | Zimmer TMT Vista-S | K133784, K111983 | Class II | ODP<br>21 CFR § 888.3060 | | Zimmer TMT TM-400* | K120203 | Class II | MAX<br>21 CFR § 888.3080<br>MQP<br>21 CFR § 888.3060 | *FDA clearance for MRI Labeling ## General 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. {9}------------------------------------------------ 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. | Product Name | Indications For Use | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ardis Interbody<br>System | The Ardis Interbody System is indicated for use with<br>autogenous bone graft as an intervertebral body fusion<br>device at one or two contiguous levels in the lumbosacral<br>region (L2-S1) in the treatment of degenerative disc disease<br>(DDD) with up to Grade 1 spondylolisthesis or retrolisthesis<br>at the involved level(s). DDD is defined as discogenic back<br>pain with degeneration of the disc confirmed by history and<br>radiographic studies. Patients with previous non-fusion spinal<br>surgery at involved level may be treated with the device.<br>Patients should be skeletally mature and have had six<br>months of non- operative treatment.<br><br>The Ardis Interbody System is implanted using a posterior or<br>transforaminal approach and is intended to be used singly or<br>in pairs with supplemental fixation. | | BAK Interbody<br>Fusion System | The BAK device is indicated for use with autogenous bone<br>graft in patients with degenerative disc disease (DDD) at one<br>or two contiguous levels form L2-S1. These DDD patients<br>may also have up to Grade I spondylolisthesis or<br>retrolisthesis at the involved levels(s). BAK devices are to be<br>implanted via an open anterior or posterior approach. DDD is<br>defined as discogenic back pain with degeneration of the disc<br>confirmed by history and radiographic studies. These<br>patients should be skeletally mature and have had six<br>months of non-operative treatment. | | Product Name | Indications For Use | | | Standard BAK devices and BAK/Proximity devices are to be<br>implanted via an open anterior or posterior approach.<br>BP/Lordotic devices are to be implanted via an open anterior<br>approach. | | | All BAK devices are also indicated for laparoscopic<br>implantation at the L4-L5 and L5-S1 levels for the same<br>clinical indications described above. | | BAK / C Anterior<br>Cervical Interbody<br>Fusion System | The BAK/C implant is indicated for use in skeletally mature<br>patients with degenerative disc disease (DDD) of the cervical<br>spine with accompanying radicular symptoms at one disc<br>level. DDD is defined as discogenic pain with degeneration of<br>the disc confirmed by history and radiographic studies.<br>BAK/C implants are used to facilitate fusion in the cervical<br>spine and are placed via an anterior approach at the C-3 to<br>C-7 disc levels using autograft bone. | | | When used as a vertebral body replacement device, the InFix<br>System is intended for use in the thoracic and/or lumbar<br>spine (T3-L5) to replace a collapsed, damaged or unstable<br>vertebral body resected or excised (i.e., partial or total<br>vertebrectomy procedures) due to tumor or trauma (i.e.,<br>fracture). The InFix System is designed to restore the<br>biomechanical integrity of the anterior, middle and posterior<br>spinal column even in the absence of fusion for a prolonged<br>period. The InFix implant is intended to be used with bone<br>graft. | | InFix Anterior<br>Lumbar System | When used as an intervertebral body fusion device, the InFix<br>System is indicated for use with autogenous bone graft at<br>one or two contiguous levels in the lumbosacral region (L2-<br>S1) in the treatment of degenerative disc disease (DDD) with<br>up to Grade 1 spondylolisthesis or retrolisthesis at the<br>involved level(s). DDD is defined as discogenic back pain<br>with degeneration of the disc confirmed by history and<br>radiographic studies. Patients with previous non-fusion spinal<br>surgery at involved level may be treated with the device.<br>Patients should be skeletally mature and have had six<br>months of non-operative treatment. When used as an<br>intervertebral body fusion device, the InFix implant is<br>intended to be used with supplemental fixation. | | | For both of the indications listed above, the InFix implant is<br>intended to be implanted via an open anterior approach. | | TraXis Vertebral<br>Body Replacement | Cadence and TraXis are vertebral body replacement devices<br>that are intended for use in the thoracic and/or thoracolumbar<br>spine (T3-L5) to replace a collapsed, damaged or unstable<br>vertebral body resected or excised (i.e., partial or total<br>vertebrectomy procedures) due to tumor or trauma (i.e.,<br>fracture). These devices are designed to restore the<br>biomechanical integrity of the anterior, middle and posterior<br>spinal column even in the absence of fusion for a prolonged<br>period. These devices are intended to be used with bone<br>graft. | # Indications for Use: {10}------------------------------------------------ {11}------------------------------------------------ # 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 ●