(135 days)
Not Found
No
The device description and intended use focus on the physical characteristics and surgical application of intervertebral fusion devices made of PEEK with radiographic markers. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an "intervertebral body fusion device" intended for spinal fusion procedures to treat degenerative disc disease and replace unstable vertebral bodies due to tumor or trauma, which are therapeutic applications.
No
This device is an intervertebral body fusion device, intended for spinal fusion procedures. Its purpose is to treat degenerative disc disease and restore spinal integrity, not to diagnose medical conditions. While diagnosis of DDD involves history and radiographic studies, the device itself is a surgical implant.
No
The device description clearly states that the SeaSpine NanoMetalene Systems are physical intervertebral fusion devices made from PEEK with markers, designed to be implanted in the spine. This is a hardware 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 text clearly describes the SeaSpine NanoMetalene Systems as implantable intervertebral fusion devices and vertebral body replacements. Their intended use is for spinal fusion procedures and replacing vertebral bodies due to conditions like degenerative disc disease, spondylolisthesis, retrolisthesis, tumor, or trauma. These are surgical procedures involving the implantation of a physical device into the body.
The device's function is to provide structural support and facilitate bone fusion within the spine, not to analyze biological samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The SeaSpine Cambria NanoMetalene® Surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.
The SeaSpine Vu aPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease 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 at least six (6) months of non-operative treatment.
When used as an intervertebral body fusion device, the SeaSpine Vu ePOD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e+POD System is intended for use with supplemental fixation. Degenerative disc disease (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.
When used as a vertebral body replacement (VBR), the SeaSpine Vu e-POD System is indicated for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e-POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e·POD System is intended for use with supplemental internal spinal fixation.
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with 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 composed of cancellous, cortical, 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.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.
When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology 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 composed of cancellous, cortical, and/or corticocancellous bone.
When used with the SpinPlate, 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. 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine 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 composed of cancellous, cortical, 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.
The Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of nonoperative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. 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 non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease 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 at least six (6) months of non-operative treatment.
No-Profile Implants w/ Screws:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile Locking Cover, 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, MQP, OVD, OVE
Device Description
The SeaSpine NanoMetalene Systems are single-use intervertebral fusion devices made from polyetheretherketone (PEEK per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The devices are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy and are provided sterile-packed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1), Cervical spine (C3-C7, C2-T1), Thoracolumbar spine (TI-L5)
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)
Non-Clinical Testing:
The SeaSpine NanoMetalene Systems have demonstrated equivalent mechanical performance to the predicate systems in accordance with requirements outlined in ASTM F1978, ASTM F1147, ASTM F1160 and ASTM F1044. In addition, the SeaSpine NanoMetalene Systems have equivalent biocompatibility and sterility to that of their predicate counterparts.
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.
K142488, K173260, K173606, K190655, K171046, K181079, K183083, K192132, K193636, K200879
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). 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, "U.S. Food & Drug Administration," written out next to it.
July 7, 2021
SeaSpine Orthopedics Corporation Aly Alvarez Assoc. Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K210497
Trade/Device Name: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu aºPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS -Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, OVD, OVE, MOP Dated: June 4, 2021 Received: June 7, 2021
Dear Aly Alvarez:
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
2
510(k) Number (if known)
K210497
Device Name
Device Name
SeaSpine Spacer System (Hollywood NanoMetalene, Hollywood VI NanoMetalene, Pacifica NanoMetalene)
Indications for Use (Describe)
Indications for Use (Describe)
When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology with ised as an intel voltonar oody fusion as or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or committed by instoly and radiographies. DDB paxients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and 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:
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3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210497
Device Name SeaSpine Cambria NanoMetalene System
Indications for Use (Describe)
Indications for Use (Describe)
The SeaSpine Cambria NanoMetalene® Surface technology is intended to be used as an I he Seaspille Calliona Nanometate Dystem vo contiguous levels (C3-C7) in skeletally mature patients witho degenerative disc disease (defined as neck pain with discogenio origin with degeneration of history of new operative treatment degenerative discusse (demical spine. Patients should have received at least six weeks of non-operative theatment and radiographic studies) of the cervical sphie. I talended to be implanted via an open, and wed with prior to treatment with the device. Devices are intensed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating 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 i ne burden time for this ocloolich evisting 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) K210497
Device Name
SeaSpine Vu aºPOD-L NanoMetalene Intervertebral Body Fusion Device
Indications for Use (Describe)
Indications for Use (Describe)
The SeaSpine Vu aPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two learly of the device is from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc allerior plate. Degenerative discuse is assimes should be skeletally mature and have had at least six (6) months of non-operative treatment.
| 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) K210497
Device Name SeaSpine Vu e.POD System
Indications for Use (Describe)
Indications for Use (Descine)
When used as an intervertebral body fusion device, the SeaSpine Vu ePOD System with NanoMetalene® surface when used as an mercented or use as adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e+POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by Degencialive dise and issues ( 1) hese patients should be skeletally mature and have had six months of non-operative treatment.
When used as a vertebral body replacement (VBR), the SeaSpine Vu e-POD System is indicated for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma the arracture). The SeaSpine Vu e-POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e·POD System is intended for use with supplemental internal spinal 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. | ||
| rend New Your Comments of Children Comments of Conce |
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)
Device Name SeaSpine Regatta Lateral System
Indications for Use (Describe)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System with NanoMetalene surface technology is indicated for use as an adjunct to fusion I he Seasonic Regaria Lateral System Mith Autoise disease (DDD, defined as back pain of discogenic origin, with in skelelally mature patients with degencially and radiographic studies). It is intended for use at either one level of the degeneration of this commined by first. The take the treatment of DDD with up to Grade 1 spondylolisthesis at the involved levels in the interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, 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.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant 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 (DDD) at the of two volumed by history and radiographic studies. The DDD patients may also have up to Grade 1 degencialism of the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with 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
7
510(k) Number (if known) K210497
Device Name
SeaSpine Vu a-POD Prime NanoMetalene Intervertebral Body Fusion Device
Indications for Use (Describe)
Indications for Use (Describe)
When used with the bone screws, the SeaSpine Vu aªPOD Prime NanoMetalene Intervertebral Body Fusion Device with When used with the bone screws, the Soubpilo 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 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 allot all to crade i spond from and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used with the SpinPlate, the SeaSpine Vu a+POD Prime NanoMetalene Intervertebral Body Fusion Device is with used will his opin into, the evalue 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The SeaSpine Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine 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 composed of cancellous, cortical, 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.
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
8
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 I he burden time for this collection of information to estination the data needed and complete time to review instructions, search existing data sources, gather and his burden estimate or any other aspect and review the collection of information. Ochastions 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 of conduct or sponsor, anays a currently valid OMB number."
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210497
Device Name Shoreline ACS (Anterior Cervical System)
Indications for Use (Describe)
Indications for Use (Describe)
The Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices I I ill Shoremie Ac s (Anchor Cervical of skeletally mature patients with degenerative disc disease intenced for allerior cervical microody nanon processed pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft radiographic studies. The Shoremie Not implanted with and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
| AND AND AND INCREAT CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR | 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
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K210497
Device Name Shoreline Cervical Interbody RT System
Indications for Use (Describe)
Indications for Use (Describe)
The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices TV S The Storeme Cervical miterbody (11 by stant with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one mended to tas in skeleadly mature patent. DDD is defined as discogenic pain with degeneration of the disc of two colligabous levels, dopending on the securents should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to within as a standatione system, are simple level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with 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
"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."
11
510(k) Number (if known)
Device Name SeaSpine Reef TO/TA System
Indications for Use (Describe)
Indications for Use (Describe)
When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface when used as an merveltedrar our institutes at one or two contiguous levels (L2?S1) in skeletally mature patients technology is mended tor spillar rasion proceanterined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved reiolismes at the involved iven's). These pasis months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and 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
12
510(k) Number (if known) K210497
Device Name SeaSpine Reef TH System
Indications for Use (Describe)
Indications of Occ (2008/10)
The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and 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
13
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210497
Device Name SeaSpine Meridian System
Indications for Use (Describe)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
Interbody Device (115) Implans (1.5, merood) meet echnology interbody is indicated for use as an adjunct to I lie Seasonic Mendrall System with Nandisease (DDD) at one or two contiguous levels from L2 to S1. These DDD tusion in pations with organetade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as I ne ocaspite werendin mith degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
No-Profile Implants w/ Screws:
No-Frome implants w/ Serews:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a I he business interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DD) 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile Locking Cover, 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 I spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (25 and 30 degrees) are intended for use with 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)
14
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 l he burden time for this collection of information is csamated to arelage the data needed and complete time to review the collection. Send comments regarding this burden estimate or any other aspect and review the collection of information. Sogestions 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
15
510(k) Summary
K210497 Page 1 of 8
| Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (619) 884-4342 (Aly) or (790) 216-5109 (Kate) | |
| (760) 683-6874 | |
| Contact person: | |
| Additional contact: | Aly Alvarez, Assoc. Manager, Regulatory Affairs |
| Kate Hunter, Director, Regulatory Affairs | |
| Date Prepared: | February 17, 2020 |
| Device Name | |
| Trade Name: | SeaSpine Spacer System – (Hollywood NanoMetalene, Hollywood VI |
| NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura | |
| NanoMetalene), | |
| Vu a•Pod L NanoMetalene, | |
| SeaSpine Vu e•Pod System, | |
| SeaSpine Vu a•Pod Prime NanoMetalene, | |
| SeaSpine Regatta Lateral System, | |
| SeaSpine Cambria System, | |
| SeaSpine Shoreline ACS - Anterior Cervical System, | |
| Shoreline Cervical Interbody RT System, | |
| SeaSpine Beachside System, and | |
| SeaSpine Reef TH System | |
| SeaSpine Meridian System | |
| Common Name: | Intervertebral body fusion device, |
| Spinal intervertebral body fixation orthosis | |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| Spinal intervertebral body fixation orthosis (21 CFR 888.3060) | |
| Class: | II |
| Product Code: | MAX (Intervertebral Fusion Device with Bone Graft, Lumbar) |
| ODP (Intervertebral Fusion Device with Bone Graft, Cervical) | |
| MQP (Spinal Vertebral Body Replacement Device) | |
| OVD (Intervertebral Fusion Device with Integrated Fixation, Lumbar) | |
| OVE (Intervertebral Fusion Device with Integrated Fixation, Cervical) |
16
K210497 Page 2 of 8
Legally Marketed Predicate Devices
| 510(k) Number | Product
Code | Trade Name | Manufacturer |
|-----------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Primary Predicate | | | |
| K142488,
K173260 | MAX,
ODP,
MQP | SeaSpine Spacer System –
(Hollywood NanoMetalene,
Hollywood VI NanoMetalene,
Pacifica NanoMetalene,
Redondo NanoMetalene,
Ventura NanoMetalene) | SeaSpine Orthopedics
Corporation |
| Additional Predicates | | | |
| K142488 | MAX, ODP | Vu a•POD-L NanoMetalene | SeaSpine Orthopedics
Corporation |
| K142488,
K173260 | MAX,
ODP,
MQP | SeaSpine Vu e•POD System | SeaSpine Orthopedics
Corporation |
| K173606 | OVD | SeaSpine Vu a•POD Prime
NanoMetalene Intervertebral
Body Fusion Device | SeaSpine Orthopedics
Corporation |
| K190655 | OVD | SeaSpine Shoreline ACS –
Anterior Cervical Standalone
System | SeaSpine Orthopedics
Corporation |
| K171046 | ODP | SeaSpine Cambria System | SeaSpine Orthopedics
Corporation |
| K181079 | MAX | SeaSpine Regatta Lateral System | SeaSpine Orthopedics
Corporation |
| K183083 | OVE,
ODP | Shoreline Cervical Interbody RT
System | SeaSpine Orthopedics
Corporation |
| K192132 | MAX | SeaSpine Reef TO/TA System
(formerly SeaSpine Beachside
System) | SeaSpine Orthopedics
Corporation |
| K193636 | MAX | SeaSpine Reef TH System | SeaSpine Orthopedics
Corporation |
| K200879 | MAX,
OVD | SeaSpine Meridian System | SeaSpine Orthopedics
Corporation |
Device Description
The SeaSpine NanoMetalene Systems are single-use intervertebral fusion devices made from polyetheretherketone (PEEK per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The devices are offered in a variety of sizes
17
and geometries to accommodate variations in pathology and patient anatomy and are provided sterile-packed.
Indications for Use
SeaSpine Spacer System - (Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene, Pacifica NanoMetalene)
When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device
SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device with The NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vua«POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease 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 at least six (6) months of non-operative treatment.
SeaSpine Vu e•POD System
When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e · POD System is intended for use with supplemental fixation. Degenerative disc disease (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.
When used as a vertebral body replacement (VBR), the SeaSpine Vu e • POD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, or otherwise unstable K201193 vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e •POD System
18
is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental internal spinal fixation.
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 with NanoMetalene® surface technology 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 composed of cancellous, cortical, and/or corticocancellous bone.
When used with the SpinPlate, 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. 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 composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene IntervertebralBody Fusion Device is intended for use with supplemental fixation.
The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine 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 composed of cancellous, cortical, 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.
Shoreline ACS (Anterior Cervical System)
The Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft
19
composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of nonoperative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
SeaSpine Cambria System
The SeaSpine Cambria NanoMetalene System with NanoMetalene® surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.
SeaSpine Regatta Lateral System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with 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 composed of cancellous, cortical, 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.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant 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 spacer component may be packedwith autogenous
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bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.
Shoreline Cervical Interbody RT System
The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. 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 non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
SeaSpine Reef TO/TA System
When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
SeaSpine Reef TH System
The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also
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have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
SeaSpine Meridian System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease 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 at least six (6) months of non-operative treatment.
No-Profile Implants w/ Screws:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile LockingCover, 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct
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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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
Summary of Technological Characteristics
The SeaSpine NanoMetalene Systems are identical to the cited predicate devices. They have identical technological characteristics to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, etc.) and performance (mechanical safety).
Non-Clinical Testing
The SeaSpine NanoMetalene Systems have demonstrated equivalent mechanical performance to the predicate systems in accordance with requirements outlined in ASTM F1978, ASTM F1147, ASTM F1160 and ASTM F1044. In addition, the SeaSpine NanoMetalene Systems have equivalent biocompatibility and sterility to that of their predicate counterparts.
Conclusions
The submitted data demonstrates that the subject SeaSpine NanoMetalene Systems have been shown to be substantially equivalent to legally marketed predicate devices for their intended use.