(143 days)
Not Found
No
The summary describes a physical intervertebral body fusion device and its components, with no mention of software, algorithms, or any form of AI/ML technology.
Yes
This device is an intervertebral body fusion device indicated for use as an adjunct to fusion in patients with degenerative disc disease, which clearly defines it as a therapeutic device.
No
The device is an intervertebral body fusion device intended to be implanted as an adjunct to fusion for patients with degenerative disc disease, which clearly indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly describes physical implants (intervertebral body fusion devices, bone screws, SpinPlate, tantalum pins) made of materials like PEEK polymer, titanium, and tantalum, intended for surgical implantation. It also mentions instruments for placement and sterilization. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "anterior intervertebral body fusion device (IBD)" used as an "adjunct to fusion" in patients with degenerative disc disease. It is an implantable device used in surgery to stabilize the spine.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical support and facilitating bone fusion.
Therefore, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate,then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with the bone screws, the SeaSpine Vu a POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a-POD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime Intervertebral Body Fusion Device, when used with bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The SeaSpine Vu aºPOD Prime Intervertebral Body Fusion Devices are anterior intervertebral body fusion devices (IBD) which can be used in combination with two Bone Screws, a SpinPlate, or both Bone Screws and SpinPlate together. When used with Bone Screws or Bone Screws and SpinPlate, the system is a stand-alone device. When used with the SpinPlate alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). The Bone Screws and SpinPlate are manufactured from Ti-6A1-4V ELI per ASTM F136.
The Vu a•POD Prime IBD spacers are comprised of PEEK-OPTIMA LT1 polymer and include large central graft windows, which are packed with bone graft prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM). Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation.
The Vu aºPOD Prime IBD NanoMetalene implants are provided in gamma sterilized packaging; the Vu a•POD Prime IBD PEEK spacer, Bone Screws, and SpinPlate are provided non-sterile for subsequent sterilization at the healthcare facility. The instruments included with the Vu a•POD Prime IBD facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to 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)
Non-Clinical Testing: Conclusions from the previously performed analysis verified that no new worst cases were created for Static Axial and Shear Compression, Dynamic Axial and Shear Compression per ASTM F2077, and Subsidence per ASTM F2267 using system's the worst-case device construct remained valid: the subject devices have equivalent mechanical strength to the predicates. Additional static screw push out testing was completed.
For the Vu aºPOD Prime IBD NanoMetalene implants, packaging, shipping and sterilization tests were previously performed to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
K162351, K121211, K101310, K080822, K073109, K101301
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration" with "Administration" written on the second line.
SeaSpine Orthopedics Corporation Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
April 13, 2018
Re: K173606
Trade/Device Name: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 16, 2018 Received: March 19, 2018
Dear Ms. Flores:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Gina Flores
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173606
Device Name
SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device
Indications for Use (Describe)
When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate,then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
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.
3
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K173606
Device Name
SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
Indications for Use (Describe)
When used with the bone screws, the SeaSpine Vu a POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a-POD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime Intervertebral Body Fusion Device, when used with bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
| 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 |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | (760) 216-5136 |
| Fax number: | (760) 683-6874 |
| Contact person: | Gina Flores, Sr. Regulatory Specialist |
| Email address: | gina.flores@SeaSpine.com |
| Date Prepared: | March 16, 2018 |
| Device Name | |
| Trade Name: | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device |
| and | |
| SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device | |
| Common Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Classification Name: | Intervertebral fusion device (21 CFR 888.3080) |
| Class: | II |
| Product Code: | OVD |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K162351 | OVD | SeaSpine Vu a•POD Prime | |
| NanoMetalene Intervertebral | |||
| Body Fusion Device System | SeaSpine Orthopedics Corp. | ||
| Additional Predicate Devices | |||
| K121211 | |||
| K101310 | |||
| K080822 | OVD | SeaSpine Vu a•POD Prime | |
| Intervertebral Body Fusion | |||
| Device System | SeaSpine Orthopedics Corp. | ||
| K073109 | MAX | STALIF TT Intervertebral | |
| Body Fusion System | Surgicraft Limited | ||
| K101301 | MAX | STALIF Midline | Centinel Spine, Linc. |
6
Device Description
The SeaSpine Vu aºPOD Prime Intervertebral Body Fusion Devices are anterior intervertebral body fusion devices (IBD) which can be used in combination with two Bone Screws, a SpinPlate, or both Bone Screws and SpinPlate together. When used with Bone Screws or Bone Screws and SpinPlate, the system is a stand-alone device. When used with the SpinPlate alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). The Bone Screws and SpinPlate are manufactured from Ti-6A1-4V ELI per ASTM F136.
The Vu a•POD Prime IBD spacers are comprised of PEEK-OPTIMA LT1 polymer and include large central graft windows, which are packed with bone graft prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM). Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation.
The Vu aºPOD Prime IBD NanoMetalene spacers are provided in gamma sterilized packaging; the Vu a•POD Prime IBD PEEK spacer, Bone Screws, and SpinPlate are provided non-sterile for subsequent sterilization at the healthcare facility. The instruments included with the Vu a•POD Prime IBD facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for use
SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device
When used with the bone screws, the SeaSpine Vu a.POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed
7
of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally. implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
When used with the bone screws, the SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a POD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu aºPOD Prime Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
8
Summary of Technological Characteristics
The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion and Vu a•POD Prime Intervertebral Body Fusion Devices are substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
Non-Clinical Testing
Conclusions from the previously performed analysis verified that no new worst cases were created for Static Axial and Shear Compression, Dynamic Axial and Shear Compression per ASTM F2077, and Subsidence per ASTM F2267 using system's the worst-case device construct remained valid: the subject devices have equivalent mechanical strength to the predicates. Additional static screw push out testing was completed.
For the Vu aºPOD Prime IBD NanoMetalene implants, packaging, shipping and sterilization tests were previously performed to validate a Sterility Assurance Level (SAL) of 10° and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.