(87 days)
No
The summary describes an implantable interbody fusion device and its accessories. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for "spinal fusion procedures" and "interbody fusion" to treat various spinal conditions, indicating a therapeutic purpose to alleviate symptoms and restore function.
No
Explanation: The device, Fortilink with TiPlus Technology, is described as an "implantable interbody fusion device" and is intended for "spinal fusion procedures." Its purpose is to facilitate fusion and provide stabilization, not to diagnose a medical condition. While the indications for use mention conditions "confirmed by patient history and radiographic studies," these refer to the pre-existing diagnoses that qualify a patient for the device, not a function performed by the device itself.
No
The device description explicitly states that the devices are "implantable interbody fusion devices" and "device specific accessories to be utilized during the procedure to insert the TiPlus Interbody devices into the disc space." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Fortilink with TiPlus Technology are "implantable interbody fusion devices intended for use in the cervical and the lumbar spine." These are surgically implanted devices, not tests performed on samples outside the body.
- Intended Use: The intended use describes surgical procedures for spinal fusion, not diagnostic testing.
Therefore, the Fortilink with TiPlus Technology is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fortilink-C with TiPlus Technology is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical 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. 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.
The Fortilink-TS with TiPlus Technology 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.
The Fortilink-TC with TiPlus Technology is indicated for transforaminal interbody fusion (IBF) of the spine in sketally mature patients with degenerative disc disease (DD) 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
Fortilink with TiPlus Technology are implantable interbody fusion devices intended for use in the cervical and the lumbar spine. The subject device inserters are device specific accessories to be utilized during the procedure to insert the TiPlus Interbody devices into the disc space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), 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)
Engineering analysis and bench top testing of the inserters demonstrated that the modified designs do not present different issues of safety and effectiveness than the predicates.
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.
K190498, K172343, K163673, K112496
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 27, 2022
Paradigm Spine % Jessica Jho Director of Regulatory Affairs Surgalign Spine Technologies 520 Lake Cook Rd Suite 315 Deerfield, Illinois 60015
Re: K213493
Trade/Device Name: Fortilink with TiPlus Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: October 29, 2021 Received: November 1, 2021
Dear Jessica Jho:
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.
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
1
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K213493
Device Name Fortilink with TiPlus Technology
Indications for Use (Describe)
The Fortilink-C with TiPlus Technology is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical 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. 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.
The Fortilink-TS with TiPlus Technology 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.
The Fortilink-TC with TiPlus Technology is indicated for transforaminal interbody fusion (IBF) of the spine in sketally mature patients with degenerative disc disease (DD) 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 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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the Surgalign logo. The logo features a stylized "S" shape in gray and blue, with small white squares inside the blue portion of the "S", resembling vertebrae. The word "urgalign" is written in blue, with a small trademark symbol next to the "n".
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Paradigm Spine GmbH
Eisenbahnstrabe 84
Wurmlingen Baden-Wurttemberg, DE 78573 | |
|----|------------------------|-------------------------------------------------------------------------------------|-----------------------------------|
| | Contact Person: | Jessica Jho
Director of Regulatory Affairs
Surgalign Spine Technologies | Contact Email: JJho@surgalign.com |
| | Date Summary Prepared: | January 3, 2022 | |
II. DEVICE
| Trade or Proprietary Name: | Fortilink with TiPlus Technology |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 21 CFR §888.3080 |
| Classification: | Class II |
| Product Code: | ODP Intervertebral Body Fusion Device with bone graft, cervical |
| MAX Intervertebral Body Fusion Device with bone graft, lumbar |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(K) | Product Name | Clearance Date |
|---|---|---|
| Primary Predicate Device | ||
| K190498 | Fortilink IBF System with TETRAfuse 3D Technology | July 5, 2019 |
| Additional Predicate Devices | ||
| K172343 | Fortilink IBF System with TETRAfuse 3D Technology | October 23, 2017 |
| K163673 | Fortilink-C With TETRAfuse 3D Technology | May 23, 2017 |
| K112496 | T-Plus/Pioneer Interbody Fusion, Vertebral Body Replacement System | September 28, 2011 |
| Reference Device | ||||
|---|---|---|---|---|
| 510(K) | Product Name | Clearance Date | ||
| K171495 | Zyston Strut Open Titanium Spacer System | January 31, 2018 |
5
K213493 - Page 2 of 9
Image /page/5/Picture/1 description: The image shows the logo for "Surgalign". The logo is in blue and gray. The "S" in Surgalign is stylized with a gray curve and blue spine-like shapes. The rest of the word is in blue.
IV. DEVICE DESCRIPTION
Fortilink with TiPlus Technology are implantable interbody fusion devices intended for use in the cervical and the lumbar spine. The subject device inserters are device specific accessories to be utilized during the procedure to insert the TiPlus Interbody devices into the disc space.
6
Image /page/6/Picture/1 description: The image shows the word "surgalign" in a stylized font. The "s" is a blue and gray curved shape with four white shapes inside. The rest of the word is in blue, with a small trademark symbol next to the "n".
Table 1. Comparison for Substantial Equivalence
| Attribute | Subject Devices | Predicate Device | Predicate Device | Reference Device | Comparison Discussion |
|---|---|---|---|---|---|
| Fortilink with TiPlus Technology | |||||
| Inserters | Fortilink IBF System with | ||||
| TETRAfuse 3D Technology | |||||
| K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion, | ||||
| Vertebral Body Replacement | |||||
| System | |||||
| K112496 | Zyston Strut Open Titanium | ||||
| Spacer System | |||||
| K171495 | |||||
| Indications for | The Fortilink-C with TiPlus | Cervical Interbody Fusion: | The Pioneer IBF/VBR System, | When used as a lumbar | The indications for use of the |
| Use | Technology is intended for spinal | When Fortilink-C is used as | when used as an IBF implant, is | intervertebral body fusion device, | subject devices are equivalent to |
| fusion procedures at one or more | cervical interbody fusion (IBF) | indicated for intervertebral body | the Zyston Strut Open Titanium | the predicate devices. No new | |
| levels (C2-T1) in skeletally mature | implants, these devices are | fusion of the spine in skeletally | Interbody Spacer System is | indications for use are introduced | |
| patients with cervical disc disease | indicated for use in skeletally | mature patients. Pioneer IBFs are | intended for spinal fusion | as a result of this submission. | |
| (defined as discogenic back pain | mature patients with | designed for use with autogenous | procedures to be used with | ||
| with degeneration of the disc | degenerative disc disease (DDD) | bone graft to facilitate fusion. | autograft and/or | ||
| and/or myelopathy with | of the cervical spine with | One device may be used per | allogenic bone graft comprised of | ||
| herniated disc and/or osteophyte | accompanying radicular | intervertebral space. Pioneer IBFs | cancellous and/or | ||
| formation on posterior endplates | symptoms at one level or two | are intended to be used with | corticocancellous bone graft in | ||
| confirmed by patient history and | contiguous levels. DDD is defined | supplemental spinal fixation | skeletally | ||
| radiographic studies), instability, | as discogenic pain with | cleared for the implanted level, | mature patients with | ||
| trauma including fractures, | degeneration of the disc | such as the Quantum, Streamline, | degenerative disc disease | ||
| deformity defined as kyphosis, | confirmed by patient history and | Contact ALP or SlimFuse systems. | ("DDD") at one or two contiguous | ||
| lordosis, or scoliosis, cervical | radiographic studies. These IBF | The Cervical IBF device in | spinal levels from | ||
| spondylotic myelopathy, spinal | devices are used to facilitate | intended for use at one level in | L2-S1. DDD is defined as | ||
| stenosis, and failed previous | interbody fusion in the cervical | the cervical spine, from C3 to T I, | discogenic back pain with | ||
| tusion at one or more levels of | spine and are placed via an | for the treatment of cervical disc | degeneration of the disc | ||
| the cervical spine with | anterior approach from C2-C3 to | disease (defined as neck pain of | confirmed by history | ||
| accompanying radicular | C7-T1 using autogenous bone | discogenic origin with | and radiographic studies. These | ||
| symptoms. Implants are to be | graft and/or allogenic bone graft | degeneration of the disc | patients should have had six | ||
| packed with autogenous bone | comprised of cancellous and/or | confirmed by history and | months of non-operative | ||
| and/or allogenic bone graft | corticocancellous bone graft. The | radiographic studies). The | treatment. | ||
| comprised of cancellous and/or | IBF devices are intended to be | cervical device is to be used in | These DDD patients may have | ||
| corticocancellous bone graft to | used with supplemental fixation | patients who have had six weeks | had a previous non-fusion spinal | ||
| facilitate fusion. This device is | of non-operative treatment | surgery at the involved spinal | |||
| Attribute | Subject Devices | Predicate Device | Predicate Device | Reference Device | Comparison Discussion |
| Fortilink with TiPlus Technology | |||||
| Inserters | Fortilink IBF System with | ||||
| TETRAfuse 3D Technology | |||||
| K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion, | ||||
| Vertebral Body Replacement | |||||
| System | |||||
| K112496 | Zyston Strut Open Titanium | ||||
| Spacer System | |||||
| K171495 | |||||
| intended to be used with an FDA- | cleared for the implanted level. | Lumbar IB's are also intended for | level(s), and may have up to | ||
| cleared supplemental fixation | Patients should have at least six | use at either one level or two | Grade 1 spondylolisthesis or | ||
| system appropriate for use in the | (6) weeks of non-operative | contiguous levels in the lumbar | retrolisthesis at the involved | ||
| cervical spine. This device is | treatment prior to treatment | spine, from L2 to SI1, for the | level(s). The | ||
| intended to be used in patients | with an interbody fusion device. | treatment of degenerative disc | Zyston Strut Open Titanium | ||
| who have had six weeks of non- | disease (DDD) with up to Grade I | Interbody Spacer System is to be | |||
| operative treatment. | Lumbar Interbody Fusion: | spondylolisthesis. ODD is defined | implanted via a posterior | ||
| When Fortilink-TS and Fortilink-L | as back pain of discogenic origin | approach | |||
| The Fortilink-TS with TiPlus | are used as lumbar interbody | with degeneration of the disc | and is to be combined with | ||
| Technology is indicated for | fusion (IBF) implants, these | confirmed by history and | supplemental fixation. The | ||
| transforaminal and posterior | devices are indicated for | radiographic studies. Lumbar IBFs | titanium fusion devices are not | ||
| interbody fusion (IBF) of the | intervertebral body fusion of the | are to be used in patients who | indicated for | ||
| spine in skeletally mature | spine in skeletally mature | have had six months of non- | vertebral body replacement. | ||
| patients with degenerative disc | patients with degenerative disc | operative treatment. | |||
| disease (DDD) and up to Grade 1 | disease (DDD) and up to Grade1 | The Pioneer IRFIVBR System, | |||
| spondylolisthesis of the lumbar | spondylolisthesis of the lumbar | when used as a VBR implant, is | |||
| spine at one level or two | spine at one level or two | intended for use in the | |||
| contiguous levels. DDD is defined | contiguous levels. DDD is defined | thoracolumbar spine (TI -L5) for | |||
| as back pain of discogenic origin | as back pain of discogenic origin | partial replacement (i.e., partial | |||
| with degeneration of the disc | with degeneration of the disc | vertebrectomy) of a diseased | |||
| confirmed by history and | confirmed by history and | vertebral body resected or | |||
| radiographic studies. These IBF | radiographic studies. These IBF | excised for the treatment of | |||
| devices are used to facilitate | devices are used to facilitate | tumors in order to achieve | |||
| interbody fusion in the lumbar | interbody fusion in the lumbar | anterior decompression of the | |||
| spine from L2 to S1 using | spine from L1-L2 to L5-S1 using | spinal cord and neural tissues, | |||
| autogenous bone graft and/or | autogenous bone graft and/or | and to restore the height of a | |||
| allogenic bone graft comprised of | allogenic bone graft comprised of | collapsed vertebral body. Pioneer | |||
| cancellous and/or | cancellous and/or | VBRs are also indicated for | |||
| corticocancellous bone graft to | corticocancellous bone graft to | treating fractures of the thoracic | |||
| Attribute | Subject Devices | Predicate Device | Predicate Device | Reference Device | Comparison Discussion |
| Fortilink with TiPlus Technology | |||||
| Inserters | Fortilink IBF System with | ||||
| TETRAfuse 3D Technology | |||||
| K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion, | ||||
| Vertebral Body Replacement | |||||
| System | |||||
| K112496 | Zyston Strut Open Titanium | ||||
| Spacer System | |||||
| K171495 | |||||
| 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. |
The Fortilink-TC with TiPlus
Technology 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 and/or | facilitate fusion. The IBF devices
are intended to be used with
supplemental fixation cleared for
the implanted level. Patients
should have at least six (6)
months of nonoperative
treatment prior to treatment
with an interbody fusion device. | and lumbar spine. Pioneer VBRs
are designed to restore the
biomechanical integrity of the
anterior, middle and posterior
spinal column, even in the
absence of fusion for a prolonged
period of time. The system must
be used with the Pioneer®
Quantum Spinal Fixation System
or supplemental internal fixation
systems cleared for the
conditions listed above (i.e.,
tumor or trauma of TI -L5).
Additionally, the Pioneer
Vertebral Spacer implant is
intended to be
used with bone graft. | | |
| Attribute | Subject Devices | Predicate Device | Predicate Device | Reference Device | Comparison Discussion |
| | Fortilink with TiPlus Technology
Inserters | Fortilink IBF System with
TETRAfuse 3D Technology
K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion,
Vertebral Body Replacement
System
K112496 | Zyston Strut Open Titanium
Spacer System
K171495 | |
| Regulations,
Product Code &
Class | 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. | 21 CFR 888.3080
ODP, MAX
Class II | 21 CFR 888.3080
21 CFR 888.3060
ODP, MAX, MQP
Class II | 21 CFR 888.3080
MAX
Class II | The subject and predicate devices
both are regulated per the
identical CFR section and FDA
product codes. There are no new
intended uses being utilized in
the subject devices as compared
to the predicate. |
| Instrument
Type | Orthopedic Manual Surgical
Instrument - interbody inserter | Orthopedic Manual Surgical
Instrument – interbody inserter | Orthopedic Manual Surgical
Instrument – interbody inserter | Orthopedic Manual Surgical
Instrument – interbody inserter | The subject devices are identical
to the predicates. |
| Biocompatibility
Patient Contact
Duration | Limited patient contact duration
(≤24 hours) | Limited patient contact duration
(≤24 hours) | Limited patient contact duration
(≤24 hours) | Limited patient contact duration
(≤24 hours) | The subject devices are identical
to the predicates. |
| Surgical
Approach | Anterior cervical
Posterior lumbar | Anterior cervical
Posterior lumbar | Anterior cervical
Posterior lumbar | Posterior lumbar | The subject devices are identical
to the predicates. |
| Footprint | Cervical
PLIF/TLIF Straight
TLIF Curved | Cervical
PLIF/TLIF Straight | TLIF Curved | TLIF Curved | The subject devices are identical
to the predicate and reference
devices. Note: Only the applicable |
| Attribute | Subject Devices | Predicate Device | Predicate Device | Reference Device | Comparison Discussion |
| | Fortilink with TiPlus Technology
Inserters | Fortilink IBF System with
TETRAfuse 3D Technology
K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion,
Vertebral Body Replacement
System
K112496 | Zyston Strut Open Titanium
Spacer System
K171495 | |
| | | | | | footprint has been identified in
this table. |
| Sterility | Non-Sterile devices provided with
validated steam sterilization
parameters to assure a SAL 10-6 | Non-Sterile devices provided with
validated steam sterilization
parameters to assure a SAL 10-6 | Non-Sterile devices provided with
validated steam sterilization
parameters to assure a SAL 10-6 | Non-Sterile devices provided with
validated steam sterilization
parameters to assure a SAL 10-6 | The subject devices are identical
to the predicates. |
| Reusable/Single
Use | Instruments are reusable | Instruments are reusable | Instruments are reusable | Instruments are reusable | The subject devices are identical
to the predicates. |
7
Surgalian:
8
Surgalian:
9
Surgalign:
10
Surgalian
11
V. INDICATIONS FOR USE
The Fortilink-C with TiPlus Technology 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 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. 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 FDAcleared 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-TS with TiPlus Technology 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.
The Fortilink-TC with TiPlus Technology 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 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.
VI. TECHNICAL COMPARISON TO PREDICATE
The technological design features of the subject devices, such as intended use, indications for use, design, function and technology, were compared to the predicates and it was demonstrated that they are substantially equivalent.
12
Image /page/12/Picture/1 description: The image shows the Surgalign logo. The logo features a stylized "S" in gray and blue, followed by the word "urgalign" in blue. The "urgalign" text is in a rounded, sans-serif font, and there is a trademark symbol next to the "n".
VII. PERFORMANCE DATA
Engineering analysis and bench top testing of the inserters demonstrated that the modified designs do not present different issues of safety and effectiveness than the predicates.
VIII. CONCLUSION
Based on the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to the legally marketed devices in regards to indication for use, intended use, design, technology, and performance.