(205 days)
Not Found
No
The summary describes a physical intervertebral body fusion device with a specific surface technology and materials. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an intervertebral body fusion device and vertebral body replacement used for spinal fusion procedures due to degenerative disc disease, tumor or trauma. It aims to restore biomechanical integrity and aid fusion, directly addressing a health condition.
No
This device is an intervertebral body fusion device, intended for surgical implantation to facilitate spinal fusion, not to diagnose a condition.
No
The device description clearly states that the device is a physical implant made from PEEK, tantalum, or Ti-6Al-4V ELI with a NanoMetalene surface technology. It is intended for surgical implantation.
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 systems as intervertebral body 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, tumor, or trauma. These are surgical implants used directly within the body, not devices that analyze samples outside the body.
The descriptions focus on the physical characteristics of the implants (materials, surface technology, sizes, geometries) and their surgical application in the spine. There is no mention of analyzing biological samples.
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 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.
The SeaSpine Vu aºPOD-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 aPOD-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 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, 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.
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 aºPOD 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 aºPOD 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 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).
The SeaSpine Cambria System 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 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 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.
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.
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 (DD). 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 spondylolisthess 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 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.
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 in volved 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 radio graphic 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 nonoperative 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, whenused 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 Spacer systems featuring NanoMetalene® surface technology are single-use intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) or Ti-6Al-4V ELI (per ASTM F136) markers for radiographic visualization, and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The devices have a central canal for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this submission is to describe NanoMetalene surface technology as providing a microscopic roughened surface with nano-scale features and to revise the indications for use with reference to the surface technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, lumbar (L2-S1), thoracolumbar spine (T1-L5), cervical (C2-T1, C3-C7)
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: Not applicable. The determination of substantial equivalence is not based on an assessment of nonclinical performance data.
Clinical Testing: Not applicable. The 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.
K173260, K142488, K173606, K201646, K171046, K200879, K183083, K192132, K193636, K201267, K201605
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 25, 2020
SeaSpine Orthopedics Corporation Ms. Jesse Albright Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K201193
Trade/Device Name: SeaSpine Spacer System NM (Hollywood VI, Pacifica, Redondo, Ventura), Vu aoPOD-L NanoMetalene; SeaSpine Vu eoPOD System; and SeaSpine Reef TH System. SeaSpine Vu aoPOD Prime NanoMetalene IBD: and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, MQP, OVD, OVE Dated: October 23, 2020 Received: October 27, 2020
Dear Ms. Albright:
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 L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K201193
Device Name
SeaSpine Spacer System (Hollywood NanoMetalene, Hollywood VI NanoMetalene, Pacifica NanoMetalene)
Indications for Use (Describe)
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 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) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
510(k) Number (if known) K201193
Device Name
SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device
Indications for Use (Describe)
The SeaSpine Vu aºPOD-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 aPOD-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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K201193
Device Name SeaSpine Vu e·POD System
Indications for Use (Describe)
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 ePOD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu ePOD 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.
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) K201193
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 aªOD 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 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 aPOD 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, corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu aºPOD 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 aºPOD 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) |
|---|
| ------------------------------------------------- |
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.
6
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) K201193
Device Name Shoreline ACS (Anterior Cervical System)
Indications for Use (Describe)
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 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 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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known) K201193
Device Name SeaSpine Cambria System
Indications for Use (Describe)
The SeaSpine Cambria System 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 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.
| 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
9
510(k) Number (if known) K201193
Device Name SeaSpine Cambria NanoMetalene System
Indications for Use (Describe)
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 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.
| 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
510(k) Number (if known) K201193
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 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.
| 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
11
510(k) Number (if known) K201193
Device Name Shoreline Cervical Interbody RT System
Indications for Use (Describe)
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.
| 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) K201193
Device Name SeaSpine Reef TO/TA System
Indications for Use (Describe)
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 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
13
510(k) Number (if known) K201193
Device Name SeaSpine Reef TH System
Indications for Use (Describe)
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)
| Research involving Data or STEM Materials | Course or Classroom Use |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
14
510(k) Number (if known) K201193
Device Name SeaSpine Meridian System
Indications for Use (Describe)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian 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 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, 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.
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)
15
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
16
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine® Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (760) 216-5176 | |
| (760) 683-6874 | |
| Contact person: | Jesse Albright, Regulatory Affairs Specialist |
| Date Prepared: | November 23, 2020 |
| Device Name(s) | |
| Trade Name(s): | SeaSpine Spacer System - (Hollywood NanoMetalene, Hollywood |
| VI NanoMetalene, Ventura NanoMetalene, Pacifica NanoMetalene) | |
| SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion | |
| Device | |
| SeaSpine Vu e•POD System | |
| SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body | |
| Fusion Device | |
| Shoreline ACS (Anterior Cervical System) | |
| SeaSpine Cambria System | |
| SeaSpine Regatta Lateral System | |
| Shoreline Cervical Interbody RT System | |
| SeaSpine Reef TO/TA System | |
| SeaSpine Reef TH System | |
| SeaSpine Meridian System | |
| Common Name(s): | Intervertebral body fusion device |
| Spinal intervertebral body fixation orthosis | |
| Classification Name(s): | Intervertebral Fusion Device with Bone Graft, Lumbar (21 CFR |
| 888.3080) | |
| Intervertebral Fusion Device with Bone Graft, Cervical (21 CFR | |
| 888.3080) | |
| Spinal Vertebral Body Replacement Device (21 CFR 888.3060) | |
| Intervertebral Fusion Device with Integrated Fixation, Lumbar (21 | |
| CFR 888.3080) | |
| Intervertebral Fusion Device with Integrated Fixation, Cervical (21 | |
| CFR 888.3080) | |
| Class: | II |
| Product Code(s): | MAX, ODP, MOP, OVD, OVE |
17
Legally Marketed Predicate Devices
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|-------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Primary Predicate(s) | | | |
| K173260 | MAX, ODP,
MQP | SeaSpine Spacer System -
(Hollywood NanoMetalene,
Hollywood VI NanoMetalene,
Ventura NanoMetalene,
Pacifica NanoMetalene);
SeaSpine Vu e•POD System | SeaSpine Orthopedics
Corporation |
| Additional Predicate(s) | | | |
| K142488 | MAX, ODP | Vu a•POD-L NanoMetalene | SeaSpine Orthopedics
Corporation |
| K173606 | OVD | SeaSpine Vu a•POD Prime
NanoMetalene Intervertebral
Body Fusion Device | SeaSpine Orthopedics
Corporation |
| K201646 | OVD | Shoreline ACS
(Anterior Cervical System) | SeaSpine Orthopedics
Corporation |
| K171046 | ODP | SeaSpine Cambria System | SeaSpine Orthopedics
Corporation |
| K200879 | MAX, OVD | SeaSpine Regatta Lateral System;
SeaSpine Meridian System | SeaSpine Orthopedics
Corporation |
| K183083 | ODP, OVE | Shoreline Cervical Interbody
RT System | SeaSpine Orthopedics
Corporation |
| K192132 | MAX | SeaSpine Beachside System | SeaSpine Orthopedics
Corporation |
| K193636 | MAX | SeaSpine Reef TH System | SeaSpine Orthopedics
Corporation |
| K201267 | MAX,
OLO | Adaptix Interbody System With
Titan NanoLOCK Surface
Technology | Medtronic Sofamor
Danek |
| K201605 | MAX,
ODP | EIT Cellular Titanium® Cervical
Cage, EIT Cellular Titanium®
ALIF Cage, EIT
Cellular Titanium® TLIF Cage,
EIT Cellular Titanium® LLIF
Cage, EIT Cellular
Titanium® T/PLIF Cage | EIT Emerging Implant
Technologies GmbH |
Device Description
The SeaSpine spacer systems featuring NanoMetalene® surface technology are single-use intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) or Ti-6Al-4V ELI (per ASTM F136) markers for radiographic visualization, and NanoMetalene, which is a one-micron thick surface layer of commercially pure
18
titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The devices have a central canal for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this submission is to describe NanoMetalene surface technology as providing a microscopic roughened surface with nano-scale features and to revise the indications for use with reference to the surface technology.
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 spondylolisthess 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 havehad 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.
SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device
The SeaSpine Vu aºPOD-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.
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, damaged, or otherwise unstable
19
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.
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 Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The SeaSpine Vu aºPOD 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 aºPOD 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 hyperlordotc 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 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 non-operative treatment.
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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 System 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 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 packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
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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 havehad 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 (DD). 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 spondylolisthess 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 havehad 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.
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 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 in volved 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.
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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 radio graphic 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 nonoperative 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, whenused 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.
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Summary of Technological Characteristics
The subject SeaSpine spacer systems featuring NanoMetalene surface technology are identical to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (i.e., operating principle, design, components, materials, sterility, manufacturing, etc.) and non-clinical performance (i.e., mechanical testing).
Non-Clinical Testing
Not applicable. The determination of substantial equivalenceis not based on an assessment of nonclinical performance data.
Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the subject SeaSpine Spacer Systems featuring NanoMetalene surface technology are substantially equivalent to the cited legally marketed predicate devices.