(88 days)
There are no reference devices for this submission.
No
The document describes a mechanical spinal plate system and its indications for use. There is no mention of AI, ML, or any software-driven analytical capabilities.
Yes
Explanation: The device is designed for "temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis and/or failed previous fusions," indicating its use in treating medical conditions.
No
Explanation: The provided text describes the Zimmer Spine Anterior Cervical and Lumbar Plate Systems as implants designed for temporary stabilization of the spine during spinal fusion. These are treatment devices, not diagnostic ones. Diagnostic devices are used to identify or detect medical conditions or diseases.
No
The device description explicitly states that the system consists of plates, bone screws, and instruments, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the Zimmer Spine Anterior Cervical and Lumbar Plate Systems as implants designed for surgical stabilization of the spine during fusion. They are physical devices implanted into the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the device falls under the category of a surgical implant or medical device used for structural support and stabilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.
The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.
The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.
The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths. The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred. The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone. The subject implants are provided non-sterile and must be sterilized by the enduser/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 and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1, C2-C7), Lumbar or lumbosacral (L1-S1) spine, Thoracic and thoracolumbar (T1-L5) spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Magnetic Resonance Imaging (MRI) testing of Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested appropriately to design controls; i.e. 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
No further device performance (bench) testing was required for this submission. The performance (bench) testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates. No further sterilization, biocompatibility and cvtotoxicity evaluation and/or testing were required for this submission. The sterilization, biocompatibility and cvtotoxicity testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122733, K111796, K052072, K990005, K013979, K140611, K132012
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
There are no reference devices for this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of human profiles facing right, with three distinct faces layered on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Zimmer Spine, Incorporated % Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K143626
Trade/Device Name: inVizia Anterior Certical Plate System, SC-AcuFix® Ant-Cer Dynamic Cervical Plating System, SC-AcuFix® Slimline® Anterior Cervical Plate System, SC-AcuFix® Thinline® Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica Anterior Cervical Plate System and Trinica® Select Anterior Cervical Plate System, V2FTM Anterior Fixation System
Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 19, 2014 Received: December 22, 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.
1
Page 2 - Ms. Donna M. Semlak
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 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,
Lori A. Wiggins -S
for 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.
510(k) Number (if known) K143626
Device Name inViZia® Anterior Cervical Plate System
Indications for Use (Describe)
The in ViZi® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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
3
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
4
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) K143626
Device Name
SC-AcuFix® Ant-Cer Dynamic Cervical Plating System
Indications for Use (Describe)
The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
5
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
6
Indications for Use
510(k) Number (if known) K143626
Device Name
SC-AcuFix® Slimline® Anterior Cervical Plate System
Indications for Use (Describe)
The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.
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
7
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
8
Indications for Use
510(k) Number (if known) K143626
Device Name
SC-AcuFix® Thinline® Anterior Cervical Plate System
Indications for Use (Describe)
The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.
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
9
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
10
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) K143626
Device Name Trinica® Anterior Lumbar Plate System
Indications for Use (Describe)
The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion. .
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
11
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
12
Indications for Use
510(k) Number (if known) K143626
Device Name
Trinica® Anterior Cervical Plate System and Trinica® Select Anterior Cervical Plate System
Indications for Use (Describe)
The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.
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
13
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
14
Indications for Use
510(k) Number (if known) K143626
Device Name V2FTM Anterior Fixation System
Indications for Use (Describe)
.
The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
15
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
16
Image /page/16/Picture/1 description: The image shows the logo for Zimmer Spine. The logo features a large, light blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in light blue. Underneath "zimmer", the word "spine" is written in a smaller font, with a line above it.
510(k) SUMMARY
Anterior Cervical and Lumbar
| Date of Summary Preparation: | March 13, 2015 |
|---|---|
| Submitter: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| USA | |
| Establishment Registration | |
| Number: | 2184052 (Minneapolis) |
| Company Contact (Primary): | Donna M. Semlak |
| Senior Regulatory Affairs Specialist | |
| Email: Donna.Semlak@zimmer.com | |
| Office: 952.857.5643 | |
| Email Fax: 952.857.5843 | |
| Common Name(s): | Appliance, Fixation, Spinal Intervertebral Body |
| Device/ Trade Names(s): | inViZia® Anterior Cervical Plate System |
| SC-AcuFix® Ant-Cer Dynamic Cervical Plating System | |
| SC-AcuFix® Slimline® Anterior Cervical Plate System | |
| SC-AcuFix® Thinline® Anterior Cervical Plate System | |
| Trinica® Anterior Lumbar Plate System | |
| Trinica® and Trinica® Select Anterior Cervical Plate System | |
| V2FTM Anterior Fixation System | |
| Device Classification: | Class II |
| Regulation Number and | |
| Product Code(s): | 21 CFR § 888.3060 / KWQ |
| Spinal intervertebral body fixation orthosis |
17
Predicate Devices:
The primary predicate device for this submission is the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate 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) or
PMA Numbers | Classification | Primary Code |
|-------------------------------------------|------------------------------|----------------|--------------------------|
| V2F TM Anterior
Fixation System | K122733 | Class II | KWQ
21 CFR § 888.3060 |
Additional Predicate Devices:
| Product Name | FDA 501(k) or
PMA Numbers | Classification | Primary Code | Product Name | Indications For Use |
|----------------------------------------------------------------------------------------------------|------------------------------|----------------|--------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| inViZia® Anterior
Cervical Plate System | K111796 | Class II | KWQ
21 CFR § 888.3060 | in ViZia ®
Anterior
Cervical Plate
System | The inViZia ® Anterior Cervical Plate System is designed for anterior interbody
screw fixation of the cervical spine at levels C2-T1.
The in ViZia ® Anterior Cervical Plate System is indicated for use in the temporary
stabilization of the anterior spine during the development of cervical spinal fusions
in patients with degenerative disc disease (as defined by neck pain of discogenic
origin with degeneration of the disc confirmed by patient history and radiographic
studies), trauma (including fractures), tumors, deformity (defined as kyphosis,
lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior
elements (pedicles) of the cervical, thoracic, or lumbar spine. |
| SC-AcuFix® Ant-Cer
Dynamic Cervical
Plating System | K052072 | Class II | KWQ
21 CFR § 888.3060 | SC-AcuFix®
Ant-Cer
Dynamic
Cervical
Plating
System | The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is indicated for
use in the temporary stabilization of the cervical spine (C2-C7) during the
development of solid spinal fusion inpatients with instability caused by the
following: degenerative disc disease (as defined by neck pain of discogenic origin
with denegation of the disc confirmed by patient history and radiographic studies),
trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity
(i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| SC-AcuFix® Slimline®
Anterior Cervical Plate
System | K990005 | Class II | KWQ
21 CFR § 888.3060 | SC-AcuFix®
Slimline®
Anterior
Cervical Plate
System | The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is indicated for
use in the temporary stabilization of the cervical spine (C2-C7) during the
development of solid spinal fusion inpatients with instability caused by the
following: degenerative disc disease (as defined by neck pain of discogenic origin
with denegation of the disc confirmed by patient history and radiographic studies),
trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity
(i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| SC-AcuFix® Thinline®
Anterior Cervical Plate
System | K013979 | Class II | KWQ
21 CFR § 888.3060 | SC-AcuFix®
Thinline®
Anterior
Cervical Plate
System | The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the
temporary stabilization of the cervical spine (C2-C7) during the development of
solid spinal fusion inpatients with instability caused by the following: degenerative
disc disease (as defined by neck pain of discogenic origin with denegation of the
disc confirmed by patient history and radiographic studies), trauma (including
fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis,
kyphosis, lordosis), pseudarthrosis, and failed previous fusions. |
| Trinica® Anterior
Lumbar Plate System | K140611 | Class II | KWQ
21 CFR § 888.3060 | Trinica®
Anterior
Lumbar Plate | The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or
anterolateral surgical approach above the bifurcation of the great vessels or via
the anterior surgical approach, below the bifurcation of the great vessels. This
system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine |
| Trinica® Anterior
Cervical Plate System
Trinica® Select
Anterior Cervical Plate
System | K132012 | Class II | KWQ
21 CFR § 888.3060 | | |
There are no reference devices for this submission.
General Device Description:
The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths.
The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred.
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The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone.
The subject implants are provided non-sterile and must be sterilized by the enduser/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 and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.
Indications for Use:
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| Product Name | Indications For Use |
|---|---|
| System | instability as a result of fracture (including dislocation and subluxation), tumor, |
| degenerative disc disease (defined as back pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic studies), | |
| pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, | |
| spinal stenosis, or a failed previous fusion. | |
| Trinica® | |
| Anterior | |
| Cervical Plate | |
| System | |
| Trinica® Select | |
| Anterior | |
| Cervical Plate | |
| System | The Trinica® and Trinica® Select Anterior Cervical Plate System is intended for |
| anterior interbody screw fixation of the cervical spine at level C2-T1. The system | |
| is indicated for use in the temporary stabilization of the anterior spine during the | |
| development of cervical spinal fusions in patients with degenerative disc disease | |
| (as defined by neck pain of discogenic origin confirmed by patient history and | |
| radiographic studies), trauma (including fractures), tumors, deformity (defined as | |
| kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. | |
| WARNING: These devices are not approved for screw attachment to the posterior | |
| elements (pedicles) of the cervical, thoracic, or lumbar spine. | |
| V2FTM | |
| Anterior | |
| Fixation | |
| System | The V2FTM Anterior Fixation System is indicated for use via the lateral or |
| anterolateral surgical approach in the treatment of thoracic and thoracolumbar | |
| (T1-L5) spine instability as a result of fracture (including dislocation and | |
| subluxation), tumor, degenerative disc disease (defined as back pain of | |
| discogenic origin with degeneration of the disc confirmed by patient history and | |
| radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed | |
| previous spine surgery. |
Summary of Technological Characteristics:
The technological characteristics remain the same between the subject Zimmer Spine Anterior Cervical and Lumbar Plate Systems as the predicate devices listed above. There are no changes to the implants (plate and bone 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.
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 Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested appropriately to design controls; i.e. 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
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- . ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
No further device performance (bench) testing was required for this submission. The performance (bench) testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates.
No further sterilization, biocompatibility and cvtotoxicity evaluation and/or testing were required for this submission. The sterilization, biocompatibility and cvtotoxicity testing remains the same for the currently marketed Zimmer Spine Anterior Cervical and Lumbar Plate Systems listed as above predicates.
Substantial Equivalence
Zimmer Spine considers the subject Zimmer Spine Anterior Cervical and Lumbar Plate Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Anterior Cervical and Lumbar Plate 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,
- No changes to the instrumentation, .
- No changes to the technological characteristics mentioned above ●
- No changes to the surgical technique steps