(128 days)
Not Found
No
The summary describes a physical interbody fusion device made from titanium using additive manufacturing. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies listed are mechanical and biocompatibility tests, not evaluations of algorithmic performance.
Yes.
The device is indicated for conditions like degenerative disc disease, instability, trauma, deformity, cervical spondylotic myelopathy, and spinal stenosis, and is used to facilitate spinal fusion and restore intervertebral height, which are therapeutic interventions.
No
This device is an interbody fusion cage, designed to facilitate spinal fusion. Its purpose is therapeutic (to treat conditions like degenerative disc disease) rather than diagnostic (to identify or determine the nature of a disease).
No
The device description explicitly states it is a physical implant made from Ti-6Al-4V ELI (ASTM F3001) by an additive manufacturing process, and the performance studies include mechanical testing and biocompatibility testing, which are relevant to physical devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The Fortilink Cages with TiPlus Technology are described as implants used to restore intervertebral height and facilitate spinal fusion. They are surgically implanted into the body.
- Intended Use/Indications for Use: The intended use clearly states that these devices are for anterior, lateral, transforaminal, and posterior interbody fusion of the spine. This is a surgical procedure performed in vivo.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
Therefore, the Fortilink Cages with TiPlus Technology are implantable medical devices used for surgical treatment, not IVDs.
N/A
Intended Use / Indications for Use
The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation.
The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radios), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature 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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment. The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer.
The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/ or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVD, OVE
Device Description
The Fortilink Cages with TiPlus Technology are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using various surgical approaches with autogenous bone graft and/or allogenic bone graft materials. The Fortilink Cages with TiPlus Technology are intended to be used from on various spinal sections, depending on the cage. These devices can used with and without supplemental fixation.
The Fortilink Cages with TiPlus Technology are made from Ti-6Al-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous and/or allogenic bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (cervical spine: C2-T1, lumbar spine: L2 to S1)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The testing of the Fortilink Ti Cages includes:
- Mechanical testing per ASTM F2077 and ASTM F2267: Static compression, static compression-shear, static torsion, dynamic compression, dynamic compression-shear, dynamic torsion, expulsion, and subsidence
- Biocompatibility testing for chemical characterization, particulate contaminations and cytotoxicity per ISO 10993.
- MRI Safety Testing per ASTM F2503-13, ASTM F2052-15, ASTM F2213-17, ASTM F2182-19e2, and ASTM F2119-07 (2013)
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.
K172888, K192718, K170830, K181644, K173347
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 7, 2020
Paradigm Spine. GmbH % Mr. Justin Eggleton Vice President, Spine Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K201453
Trade/Device Name: Fortilink Cages with TiPlus Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, OVD, OVE Dated: July 2, 2020 Received: July 2, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K201453
Device Name Fortilink-A Ti
Indications for Use (Describe)
The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation.
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
510(k) Number (if known) K201453
Device Name Fortilink-C Ti
Indications for Use (Describe)
The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radios), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
Type of Use (Select one or both, as applicable)
| ☒ Research and/or Educational Purposes Only | ☐ Commercial Purposes |
|---|---|
| --------------------------------------------------------------------------------------------- | ----------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K201453
Device Name Fortilink-L Ti
Indications for Use (Describe)
The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known) K201453
Device Name Fortilink-SA Ti
Indications for Use (Describe)
The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature 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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment.
The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer.
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
6
510(k) Number (if known) K201453
Device Name Fortilink-SC Ti
Indications for Use (Describe)
The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/ or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Number (if known) K201453
Device Name Fortilink-TC Ti
Indications for Use (Describe)
The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known) K201453
Device Name Fortilink-TS Ti
Indications for Use (Describe)
The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
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
9
K201453 510(k) Summary
| Device Trade Name: | Fortilink Cages with TiPlus Technology |
|---|---|
| Manufacturer: | Paradigm Spine GmbH |
| Eisenbahnstrasse 84 | |
| 78573 Wurmlingen, Germany | |
| Phone: +49 7461 9635990 | |
| Contact: | Alberto Jurado (Director Quality and Regulatory Affairs) |
| Paradigm Spine GmbH | |
| Eisenbahnstrasse 84 | |
| 78573 Wurmlingen, Germany | |
| Prepared by: | Mr. Justin Eggleton |
| Vice President, Spine Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| jeggleton@mcra.com | |
| Date Prepared: | June 1st, 2020 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX, ODP, OVD, OVE |
Indications for Use:
Fortilink-C Ti
The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte
K201453 510(k) Summary Page 1 of 5
10
formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
Fortilink-SC Ti
The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
Fortilink-TS Ti
The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
Fortilink-TC Ti
The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar
K201453 510(k) Summary Page 2 of 5
11
spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
Fortilink-L Ti
The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
Fortilink-A Ti
The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation.
Fortilink-SA Ti
The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature 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 I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment.
K201453 510(k) Summary Page 3 of 5
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The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer.
Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the Fortilink Cages with TiPlus Technology. The Fortilink Cages with TiPlus Technology are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using various surgical approaches with autogenous bone graft and/or allogenic bone graft materials. The Fortilink Cages with TiPlus Technology are intended to be used from on various spinal sections, depending on the cage. These devices can used with and without supplemental fixation (see Section 11).
The Fortilink Cages with TiPlus Technology are made from Ti-6Al-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous and/or allogenic bone graft.
Primary Predicate Device:
The Fortilink Cages with TiPlus Technology are substantially equivalent to the EIT Cellular Titanium Cage series line in device indications, surgical approach, design, materials, and performance.
| Manufacturer | Device Name | K-Number |
|---|---|---|
| EIT Emerging | ||
| Implant | ||
| Technologies | ||
| GmbH | EIT Cellular Titanium® Cervical Cages, EIT | |
| Cellular Titanium® PLIF Cages, EIT Cellular | ||
| Titanium® TLIF Cages, EIT Cellular | ||
| Titanium® ALIF Cages | K172888 |
Table 2: Primary Predicate Devices
Additional Predicate Devices:
The Fortilink Cages with TiPlus Technology are additional substantially equivalent to the Fortilink® Interbody Fusion Device (IFB) with TETRAfuse® 3D Technology (RTI Surgical, Inc.) (K192718), Unison®-C Anterior Cervical Fixation System (RTI Surgical, Inc.) (K170830), EIT Cellular Titanium® Lumbar Cage LLIF (EIT Emerging Implant Technologies GmbH) (K181644), Centinel STALIF M FLX™ (Centinel Spine, Inc.) (K173347), HEDRON™ Cervical Spacers (Globus Medical Inc.), AxTM Stand-Alone ALIF System (Innovasis, Inc.), and EVOL® Spinal Interbody System (Cutting Edge Spine, LLC) with respect to indications, design, and performance.
Technological Characteristics:
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The designs of the subject devices the Fortilink Cages with TiPlus Technology is based upon the same technology used by the primary predicate, EIT, to create the FDA-cleared and CE-marked EIT Cellular Titanium® PLIF, ALIF, and TLIF cages. Both the subject device and primary predicate cages are comprised of Ti-6Al-4V ELI through a 3D printing process called Selective Laser Melting (SLM), converting titanium alloy powder into a uniform, diamond mesh. The cage also contains hollow areas for bone graft packing to further facilitate fusion. Both devices were engineered by BAAT Medical, who designed the subject Paradigm Spine devices with the identical microstructure incorporated into the Fortilink cage designs.
Performance Testing Summary:
The testing of the Fortilink Ti Cages includes:
- Mechanical testing per ASTM F2077 and ASTM F2267: Static compression, static compression-shear, static torsion, dynamic compression, dynamic compressionshear, dynamic torsion, expulsion, and subsidence
- Biocompatibility testing for chemical characterization, particulate contaminations ● and cytotoxicity per ISO 10993.
- MRI Safety Testing per ASTM F2503-13, ASTM F2052-15, ASTM F2213-17, ● ASTM F2182-19e2, and ASTM F2119-07 (2013)
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
The Fortilink Cages with TiPlus Technology are substantially equivalent to the cited predicate devices with respect to its indications for use, design, function, materials, and performance.