(55 days)
Not Found
No
The document describes spinal fixation systems which are mechanical implants. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The description focuses on the physical components and their intended use for stabilization and fusion.
Yes.
The device is intended to provide fixation, stabilization, and immobilization of spinal segments as an adjunct to fusion for various conditions like degenerative disc disease, trauma, and deformities, which directly address a health condition or restore function.
No
The various systems described (Epic, Gallery, Concero, Zimmer Biomet Spinal Fixation, Alpine XC, Aspen, LPlate) are all indicated for providing fixation, stabilization, or buttressing of spinal segments, primarily as an adjunct to fusion. Their purpose is therapeutic (mechanical support and immobilization), not to diagnose a condition.
No
The device description and intended use clearly describe physical spinal fixation systems (plates, screws, etc.) used in surgical procedures, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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 text clearly describes the devices as spinal fixation systems (plates, screws, etc.) intended for surgical implantation to stabilize and immobilize spinal segments as an adjunct to fusion. They are physical implants used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples, analyze biomarkers, or provide diagnostic information based on laboratory analysis.
The device is a surgical implant used to treat structural issues in the spine, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
-
- Spinal Stenosis (indicated for L1-S1 only);
-
- Spondylolisthesis;
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
-
- Trauma (i.e., fracture, dislocation, or subluxation);
-
- Spondylolysis;
-
- Tumor;
-
- Pseudoarthrosis: and/or
-
- Failed previous fusion
The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:
-
- Pseudoarthrosis and failed previous fusions;
-
- Spondylolisthesis;
-
- Spondylolysis;
- Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
-
- Degeneration of the facets with instability and;
-
- Trauma including spinal fractures and/or dislocations.
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Alpine XC Adjustable MIS Fusion System 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 Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.
The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical 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 Aspendevice is intended for use with bone graft material, not intended for stand-alone use.
The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical 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 LPlate device is intended for use with bone graft material, not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
MRW, KWQ, NQW, KWP
Device Description
The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic, lumbar, and/or sacral spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems. There are no changes associated with this submission that alter the products intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Details of the MR environment testing are discussed within Section 19 - Electromagnetic Compatibility and Electrical Safety.
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.
K092765, K100805, K101364, K131156
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 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue box, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.
Zimmer Biomet Spine, Inc. David Pollard Regulatory Affairs Specialist 10225 Westmoor Drive Westminster. Colorado 80021
Re: K202309
Trade/Device Name: Epic™ Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, ConceroTM Facet Screw System, Alpine XCTM Adjustable Fusion System, Aspen® MIS Fusion System, L-Plate™ MIS Fusion System Regulation Number: Unclassified Regulatory Class: Class II Product Code: MRW, KWQ, NQW, KWP Dated: August 12, 2020 Received: August 14, 2020
Dear David Pollard:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801and Part 809); 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 (OS) 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 mediation-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,
Colin O'Neill, M.B.E. Assistant Director Division of Spinal Devices Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K202309
Device Name
EpicTM Anterior Thoracolumbar Plate System
Indications for Use (Describe)
The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
-
- Spinal Stenosis (indicated for L1-S1 only);
-
- Spondylolisthesis;
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
-
- Trauma (i.e., fracture, dislocation, or subluxation);
-
- Spondylolysis;
-
- Tumor;
-
- Pseudoarthrosis: and/or
-
- Failed previous fusion
The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
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) K202309
Device Name Gallery Laminoplasty Fixation System
Indications for Use (Describe)
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Type of Use (Select one or both, as applicable)
2 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) K202309
Device Name Concero™ Facet Screw System
Indications for Use (Describe)
The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:
-
- Pseudoarthrosis and failed previous fusions;
-
- Spondylolisthesis;
-
- Spondylolysis;
- Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
-
- Degeneration of the facets with instability and;
-
- Trauma including spinal fractures and/or dislocations.
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)
K202309
Device Name
Alpine XCTM Adjustable Fusion System
Indications for Use (Describe)
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Alpine XC Adjustable MIS Fusion System 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 Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||||
|---|---|---|---|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||||
| Type of Use (Select one or both, as applicable) |
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) K202309
Device Name Aspen® MIS Fusion System
Indications for Use (Describe)
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical 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 Aspendevice is intended for use with bone graft material, 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) Number (if known) K202309
Device Name L-Plate™ MIS Fusion System
Indications for Use (Describe)
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. Jumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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.
The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical 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 LPlate device is intended for use with bone graft material, 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
8
Image /page/8/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | August 12, 2020 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | David Pollard |
| Regulatory Affairs Specialist | |
| Phone: 303.253.0056 | |
| Alternate Contact | Alex Pawlowski |
| Regulatory Affairs Project Manager | |
| Phone: 303.264.8255 | |
| Trade Name(s) | Epic™ Anterior Thoracolumbar Plate System, Gallery Laminoplasty |
| Fixation System, Concero™ Facet Screw System, Alpine XC™ | |
| Adjustable Fusion System, Aspen® MIS Fusion System, L-Plate™ MIS | |
| Fusion System | |
| Common Name | Spinal Fixation System |
| Device Class | Class II |
| Classification Name | MRW - System, Facet Screw Spinal Device (Unclassified)- |
| KWQ - Appliance, Fixation, Spinal Intervertebral Body (21 CFR 888.3060) NQW - | |
| Orthosis, Spine, Plate, Laminoplasty, Metal (21 CFR 888.3050) KWP - Appliance, | |
| Fixation, Spinal Interlaminal (21 CFR 888.3050) | |
| Device Panel | Orthopedic |
Device Description & Technological Characteristics:
The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.
9
Image /page/9/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. A thin black line is located underneath the text.
Predicate Devices:
The predicate devices for this submission are the currently marketed Zimmer Spine Miscellaneous Spinal Fixation Systems, Epic Gallery, Concero, Alpine XC, Aspen and L-Plate. See Table 7-1 below for how each subject device brand corresponds to the predicate device under the same brand name.
| Subject Device Product Name
(Common) | Name (Common) | Predicate FDA 510(k)
Number |
|-----------------------------------------|---------------|--------------------------------|
| Epic | Epic | K092765 |
| Gallery | Gallery | K100805 |
| Concero | Concero | K101364 |
| Alpine XC | Alpine XC | K131156 |
| Aspen | Aspen | K131156 |
| L-Plate | L-Plate | K131156 |
Table 7-1: Predicate Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems
Summary of Technological Characteristics:
The technological characteristics of the subject Miscellaneous Spinal Fixation Systems remain identical to the currently marketed Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems (Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate) in regards to intended use, indications for use, manufacturing methods, fundamental technology, and operational principles. The only changes made to the Miscellaneous Spinal Fixation Systems, which are not subject of this submission, have been made via Letters-To-File. A summary of these changes subject to Letters-To-File and the technological characteristics of each Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems can be found in Section 13 – Device Description. The purpose of this submission is to seek clearance for modified product labeling of the subject systems by establishing the safety and compatibility of passive implants in the magnetic resonance (MR) environment.
Summary of Performance Data:
Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems. There are no changes associated with this submission that alter the products intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Details of the MR environment testing are discussed within Section 19 - Electromagnetic Compatibility and Electrical Safety.
10
Image /page/10/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the words "ZIMMER BIOMET" in a sans-serif font. The words are in a dark gray color. There is a thin black line underneath the words.
Intended Use / Indications for Use:
Each subject Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems' Indications for Use are unchanged from the predicate devices' previous clearances (Section 6 – Indications for Use).
Epic™ Anterior Thoracolumbar Plate System
The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic, lumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft in skeletally mature patients in the treatment of the following instabilities or deformities: Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies); · Spinal Stenosis (indicated for L1-S1 only);
- · Spondylolisthesis;
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- · Trauma (i.e., fracture, dislocation, or subluxation);
- · Spondylolysis;
- •Tumor;
- •Pseudoarthrosis; and/or
- •Failed previous fusion
The Epic Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
Gallery Laminoplasty Fixation System
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Concero™ Facet Screw System
The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5 mm and 4.0 mm screws and from L1 to S1 for 4.5 mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following: • Pseudoarthrosis and failed previous fusions;
- Spondylolisthesis;
- · Spondylolysis;
•Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
- · Degeneration of the facets with instability and;
- · Trauma including spinal fractures and/or dislocations.
Alpine XC™ Adjustable Fusion System
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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 (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
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Image /page/11/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a neutral color, possibly gray or a light shade of black, which contrasts with the white background.
The Alpine XC Adjustable MIS Fusion System 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 Alpine XC Adjustable MIS Fusion System device is intended for use with bone graft material, not intended for stand-alone use.
Aspen® MIS Fusion System
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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.
The Aspen device 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 Aspen device is intended for use with bone graft material, not intended for stand-alone use.
L-Plate™ MIS Fusion System
The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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 and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The LPlate device 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 LPlate device is intended for use with bone graft material, not intended for stand-alone use.
Substantial Equivalence Conclusion:
The Zimmer Biomet Miscellaneous Spinal Fixation Systems, as spinal fixation devices, are substantially equivalent to the currently marketed predicate Miscellaneous Spinal Fixation Systems in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles, as they are identical systems. Each of the subject systems are unchanged from the predicate versions of each respective system.