(162 days)
No
The document describes physical implants and fixation devices for spinal fusion, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and mechanical strength.
Yes
The device descriptions and intended uses clearly state that these implants are designed for spinal fusion in patients with specific medical conditions like degenerative disc disease, trauma, or tumors, which are treatments for the human body.
No
The provided text describes various fusion devices (Zavation IBF implants, VariSync Plate, VariSync Spacer, LABYRINTH implants, Zavation ALIF System) which are implants used for surgical treatment of spinal conditions. Their intended use is to provide structural support and facilitate bone fusion, not to diagnose medical conditions or diseases. The text mentions "degeneration of the disc confirmed by history and radiographic studies" as part of the criteria for patient selection, implying that diagnosis is made through separate studies, not by the device itself.
No
The device description clearly indicates that the devices are physical implants made from materials like PEEK and titanium alloy, intended for surgical implantation in the spine. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body (like blood, urine, or tissue) to provide information about a person's health. The intended use and device description clearly state that these devices are implants designed to be surgically placed in the spine for fusion. They do not involve the analysis of biological samples.
- The device description details the materials and physical characteristics of the implants. It does not mention any reagents, assays, or analytical processes typical of IVDs.
- The performance studies described focus on the mechanical properties of the coating and the implant itself. This is consistent with the evaluation of a medical device intended for implantation, not an IVD.
Therefore, the Zavation IBF implants, VariSync Plate, VariSync Spacer, LABYRINTH implants, and Zavation ALIF System are medical devices, specifically surgical implants, and not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material. The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVE, KWQ, OVD
Device Description
The Zavation IBF implants offers a variety of heights, widths, and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026). The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.
VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from Superior Polymers Magnolia PEEK, with tantalum markers, as specified in ASTM F2026 and F560. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The LABYRINTH implants offer a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026). The LABYRINTH implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The LABYRINTH device has a porous structure on the end plate and through the device. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided sterile.
The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine, from C2 to T1, Lumbar spine, from L2 to S1, Cervical spine (C2-C7), Cervical spine (C2-T1)
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)
Bench performance testing, biocompatibility assessment.
Coating properties were evaluated using ASTM F1147, ASTM F1044, ASTM F1160, and ASTM F1978 for: Tensile Bond Strength, Static Shear Strength, Shear Fatigue Strength, Tabor Abrasion Test.
The subject devices demonstrate substantial equivalence to the cited legally marketed predicate devices, and any differences between the subject devices and predicate devices do not impact the safety and effectiveness of subject 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.
K201367, K200084, K221049, K211306, K230731
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 10, 2024
Zavation Medical Products LLC Colby Williams Design Engineer 2 3670 Flowood Drive Flowood, Mississippi 39232
Re: K233509
Trade/Device Name: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, OVE, KWQ, OVD Dated: March 25, 2024 Received: March 26, 2024
Dear Colby Williams:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
510(k) Number (if known) K233509
Device Name Zavation IBF System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
| 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) K233509
Device Name
VariSync Plate and VariSync Spacer System
Indications for Use (Describe)
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
| 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
510(k) Number (if known) K233509
Device Name LABYRINTH System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
| 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
5
510(k) Number (if known) K233509
Device Name Zavation ALIF System
Indications for Use (Describe)
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.
The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.
| 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
510K Summary
| Date: | April 3, 2024 |
|---|---|
| Submitter: | Zavation Medical Products LLC |
| 3670 Lakeland Pkwy | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact Person: | Colby Williams |
| Type of 510(k) submission: | Traditional |
| Trade Name(s): | Zavation IBF System |
| Zavation Varisync Plate System and Varisync Spacer System | |
| LABYRINTH System | |
| Zavation ALIF System | |
| Common Name(s): | Intervertebral Fusion Device with Bone Graft, Cervical |
| Intervertebral Fusion Device with Bone Graft, Lumbar | |
| Intervertebral Fusion Device with Integrated Fixation, | |
| Cervical | |
| Intervertebral Fusion Device with Integrated Fixation, | |
| Lumbar | |
| Classification Regulation(s): | 21 CFR 888.3080 Intervertebral body fusion device |
| Device Classification: | Class II |
| Classification Panel: | Orthopedic |
| Product Code(s): | MAX, ODP, OVE, KWQ, OVD |
| Basis for submission: | Addition of ion beam assisted deposition (IBAD) Titanium |
Device Description:
The Zavation IBF implants offers a variety of heights, widths, and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical
7
composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.
VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from Superior Polymers Magnolia PEEK, with tantalum markers, as specified in ASTM F2026 and F560. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
The LABYRINTH implants offer a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026). The LABYRINTH implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The LABYRINTH device has a porous structure on the end plate and through the device. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided sterile.
The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.
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Intended Use:
Zavation IBF System
When used as a cervical intervertebral body fusion device, the Zavation IBF implants is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
Zavation Varisync Plate and Varisync Spacer System
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device is intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate,
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Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
LABYRINTH System
When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
Zavation ALIF System
The Zavation ALIF System is an anterior interbody fusion device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.
The Zavation ALIF System spacer and plate assembly are an integrated fusion device intended for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
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Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.
Materials:
The devices are manufactured from medical grade PEEK Magnolia PEEK (ASTM F2026), or Titanium (ASTM F136) with Tantalum alloy position markers (ASTM F560). The PEEK implants are available with or without titanium plasma coating on the device, or an ion beam assisted deposition (IBAD) coating. The plasma coating is made from commercially pure titanium per (ASTM F1580). The (IBAD) coating is made from Grade 2 Commercially Pure Titanium coating that meets chemical composition requirements of (ASTM F67).
Primary Predicate Device:
K201367 FlareHawk Interbody Fusion System [Integrity Implants Inc.]
Additional Predicate Device:
K200084 Zavation IBF System [Zavation] K221049 Zavation Varisync Plate System and Varisync Spacer System [Zavation] K211306 LABYRINTH System [Zavation] K230731 Zavation ALIF System [Zavation]
Technological Characteristics:
The subject device is identical in indications for use, surgical technique, instrumentation, and technological characteristics to the cleared additional predicate devices. The purpose of this submission is to include addition of an ion beam deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets the chemical composition requirements per (ASTM F67). The specifications of the titanium coating are identical to that of the primary predicate device cleared in (K201367).
Performance Data:
For this submission, coating properties were evaluated using standards ASTM F1147, ASTM F1044, ASTM F1160, and ASTM F1978. The following properties were tested:
- Tensile Bond Strength
- Static Shear Strength
- Shear Fatigue Strength
- Tabor Abrasion Test ●
Additional information on the (IBAD) coating can be found in the Master Access File of the coating vendor, N2 Biomedical.
Conclusion:
Based on bench performance testing, biocompatibility assessment, and other supporting documentation provided in this premarket notification the subject devices demonstrate
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substantial equivalence to the cited legally marketed predicate devices, and any differences between the subject devices and predicate devices do not impact the safety and effectiveness of subject devices.