(70 days)
Not Found
No
The summary describes physical intervertebral body fusion devices and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and spinal deformities, facilitating fusion in the lumbar spine. This directly addresses medical conditions to improve patient health, fitting the definition of a therapeutic device.
No
The device is an intervertebral body fusion device used to facilitate fusion in the lumbar spine, not to diagnose a condition.
No
The device description explicitly states the components are manufactured from radiolucent polymer, titanium alloy, and tantalum, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that these devices are implants designed to be surgically placed within the lumbar spine to facilitate fusion. They are structural components used in a surgical procedure, not devices used to analyze biological samples.
The text describes a surgical implant system for spinal fusion, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.
The T-PAL Titanium Spacer System is indicated for use as an intervertebral body firsion device in skeletally mature patients with degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.
The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in 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. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD
Device Description
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no dct'lpvgtdqf { 'f gxleg'f guki pgf "\q"dg'"pugt vgf 'y kaj kp"vj g'lpvgtxgt vgdtcn'f kue "ur ceglp"qtf gt"
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
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)
A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the subject devices are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the subject 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.
K150673, K151773, K160051, K100089, K151276
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 the department's name encircling a stylized graphic. The graphic depicts three human profiles facing right, layered on top of each other. The profiles are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
Synthes USA Products LLC Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K162358
Trade/Device Name: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 22, 2016 Received: August 23, 2016
Dear Eugene Bang:
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K162358 Page 1 of 3
| 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)
Device Name
T-PAL Spacer System
Indications for Use (Describe)
The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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."
FORM FDA 3881 (8/14)
PSC Publishing Securities (201) 643-6710 ELF
3
K162358 Page 2 of 3
| 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)
Device Name
T-PAL Titanium Spacer System
Indications for Use (Describe)
The T-PAL Titanium Spacer System is indicated for use as an intervertebral body firsion device in skeletally mature patients with degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.
| 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
"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."
FORM FDA 3881 (8/14)
PSC Publishing Securities (201) 643-6710 ELF
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 3 of 3
510(k) Number (if known) K162358
Device Name SYNFIX Evolution System
Indications for Use (Describe)
The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in 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. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of nonoperative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
| 510(k) Summary | |
|---|---|
| Submitter | Synthes USA Products, LLC. |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person | Eugene Bang |
| Regulatory Affairs Associate | |
| Telephone: (508) 977-3966 | |
| Fax: (508) 828-3797 | |
| Date Prepared | October 31, 2016 |
| Trade Name | T-PAL Spacer System |
| T-PAL Titanium Spacer System | |
| SYNFIX Evolution System | |
| Device Class | T-PAL and T-PAL Titanium Spacer Systems – Class II |
| SYNFIX Evolution System – Class II | |
| Product Code | T-PAL and T-PAL Titanium Spacer System – MAX |
| SYNFIX Evolution System - OVD | |
| Common Name | T-PAL and T-PAL Titanium System – Intervertebral Fusion Device With Bone Graft, Lumbar |
| SYNFIX Evolution System - Intervertebral Fusion Device With Integrated Fixation, Lumbar | |
| Classification | |
| Name | T-PAL and T-PAL Titanium System - Intervertebral Body Fusion Device, 21 CFR 888.3080 |
| SYNFIX Evolution System - Intervertebral Body Fusion Device, 21 CFR 888.3080 | |
| Primary | |
| Predicate | SYNFIX Evolution System – K150673 |
| Additional | |
| Predicate | DePuy Spine Concorde Bullet System - K151773 |
| NuVasive Interfixated Interbody System - K160051 | |
| T-PAL Spacer System - K100089 | |
| T-PAL Titanium Spacer System - K151276 |
6
| Device
Description | V/RCN"cpf "V/RCN"Vkcpkwo "Ur cegt "U{ uvgo "
Vj g"V/RCN"Ur cegt "ku"ctcfkqrwuegpvkpvgtdqf { 'hwukqp"f gxkeg"wugf 'lp"eqplwpevkqp'y kj "
uwr rigo gpvcnikpvgtpcrihkzcvkqp"\q'r tqxkf g'ust wewtcri'uvcdkkv{ 'p"ungg\cm{ "o cwtg'lpf kxf wcn0'
Vj g"V/RCN''Ur cegt 'ku"cxckcdng'"p"xctkqwu'j gki j vw"cpf "i gqo gvtkgu"\q"dguv'ceeqo o qf cg"
pf kxkf wenuo'r cyj qnqi { "cpf "cpcvqo kecreqpf kkqpu0Vj geqo r qpgpvu"qhvj ku'f gxleg"ctg"
o cpwhcewtgf 'htqo "ctcfkqnwegpvr qn{o gt "cpf "kcpkwo "cmq{0' |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | U[ PHKZ'Gxqnwkqp"U{ uvgo "
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no dct'lpvgtdqf { 'f gxleg'f guki pgf "\q"dg'"pugt vgf 'y kaj kp"vj g'lpvgtxgt vgdtcn'f kue "ur ceglp"qtf gt"
vq'r tqxkf g'ust wewtcr'uvcdkkv{ 'p"unggvcm{ "o cwtg'lpfkxkf wern10Vjg"U[ PHKZ"Gxqnwkqp'ku"
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rcyj qnqi {"cpf "cpcvqo lecrieqpf kkqpu0Vj g"eqo r qpgpw"qhj ku'f gxkeg"ctg"o cpwhcewtgf 'htqo
c'tcf kqnwegpvr qn{o gt. "kcpkwo "cmq{"cpf "\cpосимо 0' |
| Indications for
Use | V/RCN'Ur cegt "U{ uvgo " |
| | Vj g"V/RCN'Ur cegt "U{ uvgo 'ku'lpf kecvgf 'hqt "wug"cu"cppvgtxgtvgdtcri'dqf { 'hwukqp'f gxkeg'kp"
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y kj 'f gi gpgtckqp"qhj gf kue"eqphkto gf "d{ 'rckgpvj kuqt { "cpf tcf kqi ter j ke "uwwf kgu+"cv"qpg"qt"
vy q'eqpki wqwurgxgni"qhvj gwo dct"ur kpg**N4/U3+0Cffkkqpcm{ ."\j g"V/RCN'Ur cegt "U{ uvgo
ecp"dg"wugf "kp"r cvkgpu'f kei pqugf y kj "ur kpcrif ghqto kkgu"cu"cp"cf1wpev'\q'hwukqp0Vj gug"
rckgpu'uj qwf "dg"unggvcm{ "o cwtg"cpf 'j cxg"wpf gti qpg'ukz "o qpyj u"qhpqp/qr gtckxg"
vtgcvo gpvr tkqt"\q'uwti gt {0Vj gug'ko rrepvu'ctg"wugf "\qhcekkcvg'hwukqp'p"yj gho dct "ur kpg"
wukpi "cwqi gpqwu"dqpg"cpf 1qt"cmqi gple"dqpg'i tch/eqo rtkugf "qhecpegmqwu"cpf 1qt"
eqt keqecpegmqwu"dqpg'i tchoΎ j gp"wugf "cu"cp"lpvgtdqf { 'hwukqpf gxkeg'"\j gug'ko repw"ctg"
kpvgtf gf 'hqt "wug"y kij "uwrrngo gpvwrikpvgtpcrihkzcvkqp"u{uvgo ul' |
| | V/RCN"Vk.cpkwo "Ur cegt "U{ uvgo
"
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fgxkeg"p"unggvcm{ "o cwtg'rckgpu'y kyj 'f gi gpgtckxg'f kue'f kugcug"*f ghkpgf "cu'f kueqi gpke"
dcem'r ckp'y kaj 'f gi gpgtckqp"qh'j g'f kue"eqphito gf "d{ 'r cvkgpvj kuvqt { "cpf tcf kqi ter j ke"
uwf kgu+"cv'qpg"qt"y q"eqpki wqwugxgnu"qhj gwo dct "ur kpg"*N4/U3+0Cf fkkqpcm{."\j g"V/
RCN"Vk.cpkwo "Ur cegt "U{ uvgo "ecp"dg"wugf "lp'r ckgpw'f kei pqugf "y kyj "ur kpcrif ghqto kkgu"cu"cp"
cf1wpev'\q'hwukqp0Vj gug'r ckgpvw'uj qwf "dg"ungg\cm{ "o cwtg"cpf 'j cxg"wpf gti qpg"ukz"o qpyj u"
qhpqp/qr gtckxg"\tgcvo gpvrtkqt"\quwti gt {0Vj gug'ko rrepw"ctg"wugf "\qhcekkcvg'hwukqp'p"j g"
nwo det "ur kpgwukpi "cwqi gpqwu"dqpg"cpf 1qt"cmqi gpke"dqpg'i tchv'eqo rtkugf "qhecpegmqwu"
cpf Iqt"eqtkeqecpegmqwu"dqpg'i tchOY j gp"wugf "cu"cpkpvgtdqf { 'hwukqp"f gxkeg"j gug'ko rrepш"
ctg lpvgpf gf 'hqt "wug'y kaj "uwr rrgo gpvcrikpvgtpcrihkzcvkqpu{uvgo ul' |
7
| SYNFIX Evolution System | |
|---|---|
| The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device | |
| indicated for use in 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. DDD patients may also have up to | |
| Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature | |
| and have had six months of non-operative treatment. | |
| Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal | |
| deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation | |
| products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated | |
| screws. These patients should be skeletally mature and have undergone six months of non- | |
| operative treatment prior to surgery. | |
| These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or | |
| allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. | |
| Materials | The materials of the subject devices remain unchanged from the currently marketed predicate |
| devices. The devices are manufactured from PEEK OPTIMA (per ASTM F2026), tantalum | |
| (per ASTM F560), and Ti-6Al-7Nb (per ISO 5832, ASTM F1295). | |
| Summary of | |
| Technological | |
| Characteristics | The technological characteristics of the subject devices remain unchanged from their |
| currently marketed predicate versions in their design, material, performance, and intended | |
| use. | |
| Summary of | |
| the | |
| Performance | |
| Data | A literature analysis of published clinical data is provided to support the modified Indications |
| for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion | |
| devices similar to the subject devices are as safe and effective as the predicate devices for the | |
| modified Indications for Use. No additional testing was required as there were no changes to | |
| the technological characteristics of the subject devices. | |
| Conclusion | The Substantial Equivalence Justification provided in the submission demonstrates that the |
| devices are as safe and effective as the predicate devices because the intended use and | |
| technological characteristics remain unchanged. |