(127 days)
Not Found
No
The document describes spinal plating systems and their intended use for temporary stabilization during spinal fusion. The primary purpose of the submission is to establish an MR Conditional labeling claim. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
The device is described as a plating system intended for temporary stabilization during spinal fusions in patients with various medical conditions (e.g., degenerative disc disease, trauma, tumors), which aligns with the definition of a therapeutic device.
No
The devices described are plate systems intended for temporary stabilization and support during spinal fusion. They are implants used in treatment, not for diagnosing conditions.
No
The device description clearly states that the devices are "plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved." These are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that these are implantable plate systems designed for surgical fixation and stabilization of the spine. They are physical devices used within the body during surgery, not tests performed on samples outside the body.
- Lack of IVD Keywords: The text does not mention any terms related to laboratory testing, analysis of biological samples, or diagnostic procedures performed on bodily fluids or tissues.
Therefore, the devices described are surgical implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• 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
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis:
• Spondylolisthesis;
• Spinal stenosis;
• Tumors:
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• 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
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 – T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
• Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Decompression of the spinal cord following total or partial cervical vertebrectomv
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, PEK
Device Description
The previously cleared devices consist of a variety of plate systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved.
The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), thoracic and thoracolumbar (T1-L5) spine, lumbosacral (L1-S1) spine, non-cervical spine (T1-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
MR Compatibility testing per ASTM F2503 was performed. The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices.
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.
K142237, K150449, K083020, K062310, K063430, K132968, K182473
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.
Not Found
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
October 19, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Stryker Corporation Katie McNeil Senior Regulatory Affairs Specialist 2 Pearl Court Allendale. New Jersev 07401
Re: K221728
Trade/Device Name: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: September 22, 2022 Received: September 22, 2022
Dear Katie McNeil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221728
Device Name
Aviator® Anterior Cervical Plating (ACP) System
Indications for Use (Describe)
The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· 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
- · Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- · Pseudarthrosis
- Failed previous fusion
- · Decompression of the spinal cord following total or partial cervical vertebrectomy
- · Spondylolisthesis
- · Spinal stenosis
| 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) |
| 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
3
510(k) Number (if known) K221728
Device Name LITe® Plate System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Indications for Use (Describe)
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis:
- · Spondylolisthesis;
- · Spinal stenosis;
- Tumors:
- · Trauma (i.e. Fractures or Dislocation)
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
- · Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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
4
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221728
Device Name
DynaTran™ Anterior Cervical Plating (ACP) System
Indications for Use (Describe)
The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· 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
- · Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- · Pseudarthrosis
- Failed previous fusion
- · Decompression of the spinal cord following total or partial cervical vertebrectomy
- · Spondylolisthesis
- · Spinal stenosis
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
| 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221728
Device Name Reflex™ Hybrid ACP System
Indications for Use (Describe)
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 -T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Decompression of the spinal cord following total or partial cervical vertebrectomv
- · Trauma (including fractures)
- Tumors
- · Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- · Pseudoarthrosis
- · Failed previous fusions
- · Spondylolisthesis
- · Spinal stenosis
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
6
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221728
Device Name UniVise™ Spinous Process Fixation Plate
Indications for Use (Describe)
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.
| 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) Summary: Stryker Spine Plate Systems | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person : | Name: Katie McNeil |
| Phone: 201-749-8518 | |
| Email: katie.mcneil@stryker.com | |
| Date Prepared: | October 19, 2022 |
| Trade Names: | 1. Aviator® Anterior Cervical Plating (ACP) System |
- LITe® Plate System
- DynaTran™ Anterior Cervical Plating (ACP) System
- Reflex™ Hybrid ACP System
- UniVise™ Spinous Process Fixation Plate |
| Common Name: | 1. Aviator®
Anterior Cervical Plate System - LITe® Plate System
Appliance, fixation, spinal intervertebral body - DynaTran™
Anterior Cervical Plate System - Reflex™ Hybrid
Anterior Cervical Plate System - UniVise™ Spinous Process Fixation Plate
Spinous Process Fixation Plate |
| Proposed Class: | Class II |
| Classification Name: | 1. Aviator®
Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 - LITe® Plate System
Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 - DynaTran™
Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 - Reflex™ Hybrid
Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 - UniVise™ Spinous Process Fixation Plate
Spinal interlaminal fixation orthosis; 21 CFR §888.3050 |
| Product Code: | 1. Aviator®
KWQ - LITe® Plate System
KWQ - DynaTran™
KWQ |
| 510(k) Summary: Stryker Spine Plate Systems | |
| | 4. Reflex™ Hybrid
KWQ |
| | 5. UniVise™ Spinous Process Fixation Plate
PEK |
| Predicate Devices: | Primary Predicate: Aviator® (K142237) |
| | Additional Predicates: |
| | LITe® Plate System (K150449) |
| | DynaTran™ (K083020) |
| | Reflex™ Hybrid (K062310, K063430) |
| | UniVise™ Spinous Process Fixation Plate (K132968) |
| | PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN |
| | Thoracolumbar and Buttress Plate Systems (K182473) |
| Device Description: | The previously cleared devices consist of a variety of plate systems designed |
| | to provide support across implanted levels in the cervical, thoracolumbar, |
| | and lumbosacral spine until fusion is achieved.
The primary purpose of this submission is to establish an MR Conditional |
| | labeling claim for these implants. |
| Intended Use: | Aviator®
The Aviator® Anterior Cervical Plating System is intended for anterior
intervertebral screw fixation of the cervical spine at levels C2-T1. The system
is indicated for temporary stabilization of the anterior spine during the
development of cervical spine fusions in patients with the following
indications:
• 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
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical
vertebrectomy
• Spondylolisthesis
• Spinal stenosis |
| | LITe® Plate System
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are
indicated for use via a lateral or anterolateral surgical approach above the
bifurcation of the great vessels in the treatment of the thoracic and
thoracolumbar (T1-L5) spine or via an anterior approach below the
bifurcation of the great vessels in the treatment of lumbar and lumbosacral
(L1-S1) spine. The system is intended to provide additional support during
fusion in skeletally mature patients in the treatment of the following acute
and chronic instabilities or deformities: |
| 510(k) Summary: Stryker Spine Plate Systems | |
| • Degenerative Disc Disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic
studies);
• Pseudoarthrosis;
• Spondylolysis;
• Spondylolisthesis;
• Spinal stenosis;
• Tumors;
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion | |
| The LITe® Plate System Buttress Plate is intended to stabilize the allograft or
autograft at one level (T1-S1) as an aid to spinal fusion and to provide
temporary stabilization and augment development of a solid spinal fusion. It
may be used alone or with other anterior, anterolateral, or posterior spinal
systems made of compatible materials. This device is not intended for load
bearing applications. | |
| DynaTran™
The DynaTran™ Anterior Cervical Plating System is intended for anterior
intervertebral screw fixation of the cervical spine at levels C2-T1. The system
is indicated for temporary stabilization of the anterior spine during the
development of cervical spine fusions in patients with the following
indications: | |
| • 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
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudoarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical
vertebrectomy
• Spondylolisthesis
• Spinal stenosis | |
| Reflex™ Hybrid
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw
fixation of the cervical spine from C2 – T1. These systems are indicated for
temporary stabilization of the anterior spine during the development of
cervical spine fusions in patients with the following indications: | |
| • Degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic
studies)
• Decompression of the spinal cord following total or partial cervical vertebrectomv | |
| 510(k) Summary: Stryker Spine Plate Systems | |
| | • Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal stenosis |
| | UniVise™ Spinous Process Fixation Plate
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle
supplemental fixation device, intended for use at a single level in the non-
cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous
processes for the purpose of achieving supplemental fusion in the following
conditions: degenerative disc disease (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); and/or
tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with
bone graft and not intended for stand-alone use. |
| Summary of the
Technological
Characteristics | The devices in this submission possess the same technological
characteristics as their predicate devices; no changes have been made to any
of the devices. Therefore, the fundamental scientific technology of the
subject devices is the same as previously cleared devices. |
| Summary of the
Performance Data | MR Compatibility testing per ASTM F2503 was performed. The test results
demonstrate that the subject devices performance met the prescribed
acceptance criteria and are substantially equivalent to the predicate devices. |
| Conclusion | The subject devices possess the same intended use and technological
characteristics as the predicate devices. Therefore, the subject devices are
substantially equivalent. |
8
9
10