(267 days)
Not Found
No
The document describes a spinal fixation system made of metal implants and does not mention any software, algorithms, or AI/ML capabilities. The testing described is related to MRI compatibility of the physical implants.
Yes
The device is explicitly indicated to promote the fusion and provide stabilization of various parts of the spine for a range of medical conditions, which are therapeutic functions.
No.
The document describes a spinal fixation system, not a device for diagnosis. Its purpose is to promote fusion and provide stabilization, which are therapeutic interventions.
No
The device description explicitly states that the implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and/or commercially pure titanium, which are hardware components. The submission also details testing related to the physical properties of these implants in an MRI environment.
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 device as a system of implants (screws, rods, hooks, connectors) made of titanium alloy, intended for surgical implantation to stabilize and promote fusion of the spine.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Zimmer Spine Pedicle Screw-Rod System and its related components described in the text are implantable medical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Minit® Posterior Cervical-Thoracic Fixation System:
When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods: The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors: The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors: The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Nex-Link® Spinal Fixation System:
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
Nex-Link OCT® Cervical Plating System:
The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
Sequoia® Pedicle Screw System including SpeedLink IITM:
When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
ST360® Spinal Fixation System:
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
Title® 2 Polyaxial Spinal System:
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.
Product codes
NKB, KWP, MNI, MNH
Device Description
The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links)
These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only
The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Cervical spine (C1-T3), occipito-cervico-thoracic junction (occiput-T3), thoracic, lumbar, sacral spine (T1-S1), sacral iliac attachment.
Indicated Patient Age Range
skeletally mature patients.
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
Magnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately to design controls and the following ASTM Standards.
- ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Key Metrics
Not Found
Predicate Device(s)
K133291, K070282, K060683, K062505, K060634, K052566, K052247, K031985, K090060, K131980, K133086
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
Zimmer Spine, Incorporated Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K142752
Trade/Device Name: Minit® Posterior Cervical-Thoracic Fixation System, Nex-Link® Spinal Fixation System, Nex-Link OCT® Cervical Plating System, Sequoia® Pedicle Screw System including SpeedLink IITM, ST360® Spinal Fixation System, and Title® 2 Polyaxial Spinal System
Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH Dated: May 18, 2015 Received: May 19, 2015
Dear Ms. Semlak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
1
Page 2 - Ms. Donna M. Semlak
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K142752
Device Name
Minit(R) Posterior Cervical-Thoracic Fixation System
Indications for Use (Describe)
When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K142752
Device Name Nex-Link(R) Spinal Fixation System
Indications for Use (Describe)
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
510(k) Number (if known) K142752
Device Name
Nex-Link OCT(R) Cervical Plating System
Indications for Use (Describe)
The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
5
510(k) Number (if known) K142752
Device Name
Sequoia(R) Pedicle Screw System including SpeedLink II(TM)
Indications for Use (Describe)
When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K142752
Device Name ST360°(R) Spinal Fixation System
Indications for Use (Describe)
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K142752
Device Name Title(R) 2 Polyaxial Spinal System
Indications for Use (Describe)
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
Image /page/8/Picture/1 description: The image contains the logo for Zimmer Spine. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, with the word "spine" underlined and in a smaller font size.
510(k) SUMMARY
Pedicle Screw-Rod Systems
| Date of Summary Preparation: | May 18, 2015 |
|---|---|
| Submitter: | Zimmer Spine, Inc. |
| 7375 Bush Lake 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): | Pedicle Screw-Rod Systems |
| Device/Trade Names(s): | Minit ® Posterior Cervical-Thoracic Fixation System |
| Nex-Link ® Spinal Fixation System | |
| Nex-Link OCT ® Cervical Plating System | |
| Sequoia ® Pedicle Screw System including SpeedLink II ™ | |
| ST360 ® Spinal Fixation System | |
| Title ® 2 Polyaxial Spinal System | |
| Device Classification: | Class III / II |
| Regulation Number and | |
| Product Code(s): | 21 CFR § 888.3050 / KWP |
| U/c@•ã, Fixation, Spinal Inter æ{ ã æ | |
| 21 CFR § 888.3070 / MNI / MNH | |
| Orthosis, Spinal Pedicle Fixation | |
| 21 CFR § 888.3070 / NKB | |
| Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
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Predicate Devices:
The primary predicate device for this submission is the currently marketed Zimmer Spine ST360 Spinal Fixation System listed below. The purpose of this submission is to update product specific package inserts (IFU) with MRI Conditional language only.
| Product Name | FDA 501(k) or
PMA Numbers | Classification | Primary Code |
|--------------|------------------------------|----------------|--------------------------|
| ST360 | K133291 | Class III / II | NKB
21 CFR § 888.3070 |
Additional Predicate Devices:
| Product Name | FDA 501(k) Numbers | Classification | Primary Code |
|---|---|---|---|
| Minit | K070282 | Class III / II | NKB |
| 21 CFR § 888.3070 | |||
| Minit | K060683 | Class II | KWP |
| 21 CFR § 888.3050 | |||
| NexLink | K062505 | Class II | MNI |
| 21 CFR § 888.3070 | |||
| NexLink | K060634 | ||
| NexLink | K052566 | ||
| NexLink | K052247 | ||
| NexLink | K031985 | ||
| NexLink | |||
| NexLink OCT | K090060 | Class II | KWP |
| 21 CFR § 888.3050 | |||
| Sequoia | |||
| (Speedlink) | K131980 | Class III / II | NKB |
| 21 CFR § 888.3070 | |||
| Title 2 | |||
| (Northstar) | K133086 | Class III / II | NKB |
| 21 CFR § 888.3070 |
There are no reference devices for this submission.
General Device Description:
The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links)
These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only
The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.
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| System | Indications for Use |
|---|---|
| Minit® Posterior | |
| Cervical- | |
| Thoracic | |
| Fixation System | When intended to promote fusion of the cervical spine and the thoracic spine, (CIT3), the |
| Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the | |
| following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, | |
| failed previous fusion and/or tumors. | |
| Hooks and Rods | |
| The hooks and rods are also intended to provide stabilization to promote fusion | |
| following reduction of fracture/dislocation or trauma in the cervical/upper thoracic | |
| (C1-T3) spine. | |
| Screws/Connectors | |
| The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. | |
| Screws are not intended to be placed in the cervical spine. | |
| Axial and Offset Rod Connectors | |
| The Minit Posterior Cervical and Upper Thoracic Fixation System can also be | |
| linked to the TiTLE and TiTLE 2 System offered by Endius Inc. using the Axial | |
| Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors. | |
| Nex-Link® Spinal | |
| Fixation System | When intended to promote fusion of the cervical spine and the thoracic spine, (C I-T3), the |
| NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic | |
| origin with degeneration of the disc confirmed by history and radiographic studies), | |
| spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. | |
| Hooks and rods are also intended to provide stabilization to promote fusion following | |
| reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C I-T3) spine. | |
| The use of multiaxial screws is limited to placement in T I-T3 in treating thoracic conditions | |
| only. The multiaxial screws are not intended to be placed in the cervical spine. | |
| Nex-Link | |
| OCT® | |
| Cervical | |
| Plating System | The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as |
| an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) | |
| for the following indications: degenerative disc disease (neck pain of discogenic origin with | |
| degeneration of the disk as confirmed by patient history and radiological studies), | |
| spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, | |
| occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors. | |
| The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm | |
| threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow | |
| for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading | |
| Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional | |
| stabilization of the cervical spine for the indications specified above. | |
| Sequoia® Pedicle | |
| Screw | |
| System | |
| including | |
| SpeedLink II™ | When intended for pedicle screw fixation from T1 –S1, the Sequoia Pedicle Screw System is |
| intended to provide immobilization and stabilization of spinal segments in skeletally mature | |
| patients as an adjunct to fusion in the treatment of the following acute and chronic | |
| instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc | |
| disease (defined as discogenic back pain with degeneration of the disc confirmed by history | |
| and radiographic studies), degenerative spondylolisthesis with objective evidence of | |
| neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, | |
| kyphosis, and/or lordosis), tumor and failed previous fusion. | |
| As pedicle screw system places between L3 and S1, the indications include Grade 3 or | |
| Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the | |
| posterior lumbosacral spine, and intended to be removed after the solid fusion is | |
| established. | |
| When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), | |
| the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with | |
| associated paralysis or spasticity, scoliosis with deficient posterior elements such as that | |
| resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late | |
| deformity), degenerative disc disease (back pain of discogenic origin with degenerative of | |
| the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal | |
| stenosis and failed previous fusion. | |
| System | Indications for Use |
| After solid fusion occurs, these devices serve no functional purpose and should be removed. | |
| In most cases, removal is indicated because the implants are not intended to transfer or | |
| support forces developed during normal activities. Any decision to remove the device must | |
| be made by the physician and the patient, taking into consideration the patient's general | |
| medical condition and the potential risk to the patient of a second surgical procedure. | |
| ST360°® Spinal | |
| Fixation System | The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and non- |
| pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as | |
| back pain of discogenic origin with degeneration of the disc confirmed by history and | |
| radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, | |
| deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, | |
| and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients. | |
| When used as a sacral screw system, the ST360° Spinal Fixation System is intended for | |
| use in the treatment of degenerative disc disease (as defined as chronic back pain of | |
| discogenic origin with degeneration of the disc confirmed by history and radiographic | |
| studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, | |
| loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, | |
| pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of | |
| the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. | |
| Transverse connectors of the system are intended for posterior thoracic and/or lumbar use | |
| only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the | |
| sacrum. | |
| Title® 2 Polyaxial | |
| Spinal System | The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as |
| discogenic back pain with degeneration of the disc confirmed by history and radiographic | |
| studies). Levels of fixation are for the thoracic, lumbar and sacral spine. | |
| The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide | |
| immobilization and stabilization of spinal segments in skeletally mature patients as an | |
| adjunct to fusion in the treatment of the following acute and chronic instabilities or | |
| deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with | |
| objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal | |
| tumor, and failed previous fusion (pseudoarthrosis). | |
| The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe | |
| spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous | |
| bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be | |
| removed after solid fusion is attained. Levels of fixation are from L3-S1. | |
| In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is | |
| indicated for sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw | |
| indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back | |
| pain with degeneration of the disc confirmed by history and radiographic studies), | |
| deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion | |
| surgery. | |
| The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and | |
| Upper Thoracic Fixation System. |
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Summary of Technological Characteristics:
The technological characteristics remain the same between the subject and predicate devices. There are no changes to the implants (rods and/or screws) and instrumentation within this submission. This submission is only proposing labeling updates regarding interactions with magnetic fields during Magnetic Resonance Imaging (MRI) with respect to patient safety.
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Summary of Performance Testing:
Maqnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately to design controls and the following ASTM Standards.
- ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically ● Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts ● from Passive Implants
- ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency ● Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically ● Induced Torque on Medical Devices in the Magnetic Resonance Environment
Conclusion:
Zimmer Spine considers the subject Zimmer Spine Pedicle Screw-Rod Systems to be substantially equivalent to the currently marketed (predicate) Zimmer Spine Pedicle Screw-Rod Systems listed as above because:
- No changes to the intended use,
- No changes to mechanical and functional performance. ●
- No changes to the functional scientific technology, ●
- No changes to the implants (screws or rods), ●
- No changes to the instrumentation, ●
- No changes to the technological characteristics mentioned above ●
- No changes to the surgical technique steps ●