(55 days)
No
The summary describes a physical intervertebral body fusion and vertebral body replacement device made of PEEK and tantalum, along with associated instruments. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies focus on mechanical, packaging, and sterilization testing, not algorithmic performance.
Yes.
The device is intended for spinal fusion procedures due to degenerative disc disease, tumor, or trauma/fracture, aiming to restore biomechanical integrity and provide anterior decompression. These uses directly address and treat medical conditions, defining it as a therapeutic device.
No
This device is an intervertebral fusion device, designed to promote spinal fusion by acting as a disc spacer and holding bone graft, not for diagnosing medical conditions.
No
The device description clearly details physical implants made from PEEK and tantalum, along with instruments for placement. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an implantable medical device intended for spinal fusion procedures and vertebral body replacement. It is surgically placed within the body to provide structural support and promote bone fusion.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens outside of the body.
Therefore, this device falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SeaSpine Spacer System (NanoMetalene)-Hollywood, Hollywood VI, Ventura, Pacifica:
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
SeaSpine Spacer System- Hollywood, Hollywood VI, Ventura, Pacifica:
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer 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. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.
SeaSpine Vu e·POD System:
When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device 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 autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are 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 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 Vu e•POD VBR 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR System is intended for use with supplemental internal spinal fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD, are intervertebral fusion devices intended to promote spinal fusion by acting as a disc spacer and holding autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone. The implants have teeth on the superior and inferior surfaces and a central canal for receiving the autograft. The devices are available in a variety of shapes, lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All implants are manufactured from PEEK (per ASTM F2026) with radiographic markers manufactured from tantalum (per ASTM F560). The implants are offered either in all PEEK (ASTM F2026) or coated with commercially pure titanium (ASTM F67), NanoMetalene.
The NanoMetalene spacers are provided in gamma sterilized packaging, while the PEEK spacers are provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2-S1, Thoracolumbar spine (T1 to 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:
There are no changes to the design, materials, specifications or manufacture of the implants, therefore no mechanical testing was performed.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSVAAMI ST-72:2011.
Clinical Testing:
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K162715, K142488, K102026, K082310, K082712
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.
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
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December 4, 2017
SeaSpine Orthopedics Corporation Ms. Gina Flores Sr. Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K173260
Trade/Device Name: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: October 9, 2017 Received: October 10, 2017
Dear Ms. Flores:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Gina Flores
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173260
Device Name
SeaSpine Spacer System (NanoMetalene)-Hollywood, Hollywood VI, Ventura, Pacifica
Indications for Use (Describe)
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous 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
Indications for Use
510(k) Number (if known) K173260
Device Name
SeaSpine Spacer System- Hollywood, Hollywood VI, Ventura, Pacifica
Indications for Use (Describe)
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
When used as a vertebral body replacement device (VBR) the Seaser System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer 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. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft come graft composed of cancellous and/or corticocancellous bone.
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."
4
Indications for Use
510(k) Number (if known) K173260
Device Name SeaSpine Vu e·POD System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device 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 autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are 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 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 Vu e POD VBR 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
K173260 - page 1 of 4
Image /page/5/Picture/2 description: The image contains the logo for SeaSpine. The logo consists of a stylized wave graphic in shades of blue and gray, followed by the word "SeaSpine" in orange. A gray line is located underneath the word "SeaSpine".
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | (760) 216-5136 |
| Fax number: | (760) 683-6874 |
| Contact person: | Gina Flores, Sr. Regulatory Specialist |
| Email address: | gina.flores @ seaspine.com |
| Date Prepared: | October 24, 2017 |
Device Name
| | Trade Name | Common
Name | Classification
Name | Class | Product
Code |
|---|--------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|----------|-----------------|
| 1 | SeaSpine Spacer System (NanoMetalene)-
Hollywood, Hollywood VI, Ventura, Pacifica | Intervertebral Fusion
Device with Bone
Graft, Lumbar | Intervertebral Body Fusion
Device (21 CFR 888.3080) | Class II | MAX |
| 2 | SeaSpine Spacer System -
Hollywood, Hollywood VI, Ventura, Pacifica | Intervertebral Fusion
Device with Bone
Graft, Lumbar | Intervertebral Body Fusion
Device (21 CFR 888.3080) | Class II | MAX |
| | | Spinal Vertebral Body
Replacement Device | Spinal Intervertebral Body
Fixation Orthosis (21 CFR
888.3060) | | MQP |
| 3 | SeaSpine Vu e-POD System | Intervertebral Fusion
Device with Bone
Graft, Lumbar | Intervertebral Body Fusion
Device (21 CFR 888.3080) | Class II | MAX |
| | | Spinal Vertebral Body
Replacement Device | Spinal Intervertebral Body
Fixation Orthosis (21 CFR
888.3060) | | MQP |
Legally Marketed Predicate Devices
-
- SeaSpine Spacer System (NanoMetalene)-Hollywood, Hollywood VI, Ventura, Pacifica:
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K162715, | |||
| K142488, | |||
| K102026 | MAX | SeaSpine Spacer System | |
| Hollywood, Hollywood VI, | |||
| Ventura | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional PREDICATE Devices | |||
| K162351 | OVD | Vu a•POD Prime | |
| NanoMetalene | SeaSpine Orthopedics | ||
| Corporation |
6
Image /page/6/Picture/2 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic on the left, followed by the word "SeaSpine" in orange. The wave graphic is made up of three curved lines in shades of blue. A gray line is located underneath the text.
2. SeaSpine Spacer System-Hollywood, Hollywood VI, Ventura, Pacifica:
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K082310 | MQP, MAX | SeaSpine Spacer System: | |
| Hollywood, Hollywood VI, | |||
| Ventura, Pacifica | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional PREDICATE Devices | |||
| K162351 | OVD | Vu a•POD Prime | |
| NanoMetalene | SeaSpine Orthopedics | ||
| Corporation |
-
- SeaSpine Vu e·POD System:
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K082712 | MQP, MAX | SeaSpine Vu e-POD System | |
| (PEEK) | SeaSpine Orthopedics | ||
| Corporation | |||
| (originally manufactured | |||
| by Theken, LLC) | |||
| Additional PREDICATE Devices | |||
| K162351 | OVD | Vu a•POD Prime | |
| NanoMetalene | SeaSpine Orthopedics | ||
| Corporation |
7
Device Description
The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD, are intervertebral fusion devices intended to promote spinal fusion by acting as a disc spacer and holding autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone. The implants have teeth on the superior and inferior surfaces and a central canal for receiving the autograft. The devices are available in a variety of shapes, lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All implants are manufactured from PEEK (per ASTM F2026) with radiographic markers manufactured from tantalum (per ASTM F560). The implants are offered either in all PEEK (ASTM F2026) or coated with commercially pure titanium (ASTM F67), NanoMetalene.
The NanoMetalene spacers are provided in gamma sterilized packaging, while the PEEK spacers are provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for use
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
SeaSpine Spacer System- Hollywood, Hollywood VI, Ventura, Pacifica
When used as an intervertebral body fusion device, the system 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer 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
8
Image /page/8/Picture/2 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic on the left, followed by the word "SeaSpine" in orange. The wave graphic is made up of several curved lines in shades of blue and gray, suggesting movement. The overall design is clean and modern.
period. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.
SeaSpine Vu e·POD System
When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are 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 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 Vu e•POD VBR 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR System is intended for use with supplemental internal spinal fixation.
Summary of Technological Characteristics
The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, and Vu e-POD System and the predicate devices have the same operational principle; they act as a disc spacer and hold bone graft to promote fusion in the spine. The SeaSpine Spacer System, and Vu e-POD are substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
Non-Clinical Testing
There are no changes to the design, materials, specifications or manufacture of the implants, therefore no mechanical testing was performed.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSVAAMI ST-72:2011.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD Systems are substantially equivalent to the cited legally marketed predicate devices.