(115 days)
Not Found
No
The summary describes physical interbody fusion devices and their materials, without mentioning any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is an intervertebral body fusion system indicated for the treatment of degenerative disc disease and acts as a partial vertebral body replacement to facilitate fusion and provide stability.
No
The device is an intervertebral body fusion cage intended for the treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly states that the device consists of physical implants (cages and plates) made from materials like PEEK and titanium alloy, intended for surgical implantation. This is a hardware medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these devices are implants (intervertebral cages) used for surgical fusion of the spine. They are physical devices inserted into the body to provide structural support and facilitate bone growth.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The devices are used directly within the body.
Therefore, these devices fall under the category of implantable medical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Avenue® L Lateral Lumbar Cage: The Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
Avenue® T TLIF Cage System: The Avenue® T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
ROI-A® ALIF Cage System: The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
ROI-T® Implant System: The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, MQP
Device Description
The Avenue L Lateral Lumbar Cage is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA " LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L Lateral Lumbar Cage is available with VerteBRIDGE® titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, which may be used in addition to supplemental fixation. The Avenue L Lateral Lumbar Cage is designed for placement using a lateral surgical approach.
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T TLIF Cage System is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T TLIF Cage System is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T TLIF Cage System have a hollow central cavity to contain autogenous bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T TLIF Cage System via an integral locking pin.
The Avenue T TLIF Cage System is manufactured from PEEK-OPTIMA LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy. The Avenue T TLIF Cage System are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.
The ROI-A ALIF Cage System is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant to facilitate visibility in x-ray imaging. The subject device is designed for placement using either an anterior or anterolateral approach. The ROI-A ALIF Cage System implants feature two slots which allow for use with device-specific integrated fixation - the ROI-A VerteBRIDGE anchoring plate. The ROI-A ALIF Cage System VerteBRIDGE anchoring plate is made of titanium alloy (Ti-6Al-4V, ASTM F136) and can be inserted to obtain fixation to the vertebral bone and create a standalone lumbar interbody fusion cage construct.
The ROI-T Implant System consists of crescent shaped cages in a variety of heights and lordotic angles. The ROI-T Implant System implant has an enclosed graft space design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The ROI-T Implant System PEEK cages are designed to be inserted via a transforaminal approach. The ROI-T Implant System cages are manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers (ASTM F560) embedded in the implant to facilitate visibility during x-ray imaging.
The purpose of the subject 510(k) was to expand the indications to include use with allograft in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 to S1 (for all devices in their primary indication).
Thoracolumbar spine (from T1 to L5) for the ROI-T® Implant System when used as a vertebral body replacement device.
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modification for this device and that the devices was substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Avenue® L Lateral Lumbar Cage (K113285), Avenue® T TLIF Cage (K142645), ROI-A® ALIF Cage System (K110327), ROI-T® Implant System (K082262)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
LDR Spine USA % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street NW, 12th Floor Washington, District of Columbia 20005
Re: K153495
Trade/Device Name: Avenue® L Lateral Lumbar Cage, Avenue® T TLIF Cage System, ROI-A® ALIF Cage System, ROI-T® Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, MQP Dated: February 23, 2016 Received: February 24, 2016
Dear Mr. Eggleton:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); 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 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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153495
Device Name Avenue® L Lateral Lumbar Cage
Indications for Use (Describe)
The Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153495
Device Name Avenue® T TLIF Cage System
Indications for Use (Describe)
The Avenue® T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153495
Device Name ROI-A® ALIF Cage System
Indications for Use (Describe)
The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153495
Device Name ROI-T® Implant System
Indications for Use (Describe)
The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T® Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft 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
6
510(k) Summary
| Device Trade Name: | Avenue® L Lateral Lumbar Cage
Avenue® T TLIF Cage System
ROI-A® ALIF Cage System
ROI-T® Implant System |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | LDR Spine USA
13785 Research Boulevard, Suite 200
Austin, TX 78750
Phone: (512) 344-3333 |
| Contact: | Mr. Brad Strasser
Manager, U.S. Regulatory Affairs
LDR Spine USA |
| Prepared by: | Mr. Justin Eggleton
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
jeggleton@mcra.com |
| Date Prepared: | March 30, 2016 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device
21 CFR §888.3060, Spinal intervertebral body fixation orthosis |
| Class: | II |
| Product Codes: | MAX, OVD, MQP |
Avenue® L Lateral Lumbar Cage
The Avenue® L Lateral Lumbar Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
7
Avenue® T TLIF Cage System
The Avenue® T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
ROI-A® ALIF Cage System
The ROI-A® ALIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
ROI-T® Implant System
The ROI-T® Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.
8
Device Description:
The Avenue L Lateral Lumbar Cage is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA " LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L Lateral Lumbar Cage is available with VerteBRIDGE® titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, which may be used in addition to supplemental fixation. The Avenue L Lateral Lumbar Cage is designed for placement using a lateral surgical approach.
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T TLIF Cage System is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T TLIF Cage System is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T TLIF Cage System have a hollow central cavity to contain autogenous bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T TLIF Cage System via an integral locking pin.
The Avenue T TLIF Cage System is manufactured from PEEK-OPTIMA LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy. The Avenue T TLIF Cage System are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.
The ROI-A ALIF Cage System is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant to facilitate visibility in x-ray imaging. The subject device is designed for placement using either an anterior or anterolateral approach. The ROI-A ALIF Cage System implants feature two slots which allow for use with device-specific integrated fixation - the ROI-A VerteBRIDGE anchoring plate. The ROI-A ALIF Cage System VerteBRIDGE anchoring plate is made of titanium alloy (Ti-6Al-4V, ASTM F136) and can be inserted to obtain fixation to the vertebral bone and create a standalone lumbar interbody fusion cage construct.
The ROI-T Implant System consists of crescent shaped cages in a variety of heights and lordotic angles. The ROI-T Implant System implant has an enclosed graft space design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The ROI-T Implant System PEEK cages are designed to be inserted via a transforaminal approach. The ROI-T Implant System cages are manufactured from
9
medical grade PEEK OPTIMA LT1 in accordance with ASTM F2026 and has tantalum markers (ASTM F560) embedded in the implant to facilitate visibility during x-ray imaging.
The purpose of the subject 510(k) was to expand the indications to include use with allograft in the lumbar spine.
Predicate Devices:
Primary Predicate: Avenue® L Lateral Lumbar Cage (K113285) Avenue® T TLIF Cage (K142645) ROI-A® ALIF Cage System (K110327) ROI-T® Implant System (K082262)
Additional Predicates: Orthofix FORZA® Spacer System (K152475) Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ (K150643).
Comparison of Technological Characteristics
The predicate Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System and ROI-T Implant System (K113285, K142645, K110327, K090507, and K082262), Orthofix FORZA® Spacer System (K152475) and Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE IIIM, and MIDLINE II-Ti™ (K150643) are similar in indications for use, intended use, design, material, and performance, and are all cleared devices.
Summary of Clinical Information
A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modification for this device and that the devices was substantially equivalent to the predicate devices.
Conclusion:
This 510(k) was submitted on behalf of the Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System. ROI-A ALIF Cage System and ROI-T Implant System to expand the indications for use to include use with allograft in lumbar interbody fusions. Substantial equivalence with respect to indications for use, intended use, design, and performance was determined in response to sufficient comparisons to a predicate device.