Fortilink with TiPlus Technology

K213493 · Paradigm Spine · ODP · Jan 27, 2022 · Orthopedic

Device Facts

• Record ID: K213493
• Device Name: Fortilink with TiPlus Technology
• Applicant: Paradigm Spine
• Product Code: ODP · Orthopedic
• Decision Date: Jan 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

Fortilink with TiPlus Technology consists of implantable interbody fusion devices and specific manual surgical inserters; used in cervical and lumbar spine fusion procedures. Devices are packed with autogenous or allogenic bone graft to facilitate fusion; must be used with FDA-cleared supplemental fixation. Inserters are used by surgeons in clinical settings to place implants into the disc space. System provides structural support to the intervertebral space to promote fusion; benefits patients by addressing instability, deformity, and degenerative conditions. Inserters are reusable manual instruments.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by engineering analysis and bench top testing of the inserters.

Technological Characteristics

Interbody fusion devices and manual surgical inserters. Materials and design are consistent with predicate devices. Non-sterile, reusable instruments; validated steam sterilization (SAL 10-6).

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion. Cervical (C2-T1): discogenic pain, myelopathy, herniated disc, osteophyte formation, instability, trauma, deformity (kyphosis/scoliosis), spondylotic myelopathy, spinal stenosis, failed previous fusion. Lumbar (L2-S1): degenerative disc disease (DDD), Grade 1 spondylolisthesis. Contraindications: patients without skeletal maturity; lumbar patients without 6 months non-operative treatment; cervical patients without 6 weeks non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fortilink IBF System with TETRAfuse 3D Technology (K190498)
• Fortilink IBF System with TETRAfuse 3D Technology (K172343)
• Fortilink-C With TETRAfuse 3D Technology (K163673)
• T-Plus/Pioneer Interbody Fusion, Vertebral Body Replacement System (K112496)

Reference Devices

• Zyston Strut Open Titanium Spacer System (K171495)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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.

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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<br>Eisenbahnstrabe 84<br>Wurmlingen Baden-Wurttemberg, DE 78573 | |
|----|------------------------|-------------------------------------------------------------------------------------|-----------------------------------|
| | Contact Person: | Jessica Jho<br>Director of Regulatory Affairs<br>Surgalign Spine Technologies | Contact Email: [e-mail] |
| | 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<br>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 | | |

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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.

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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<br>Inserters | Fortilink IBF System with<br>TETRAfuse 3D Technology<br>K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion,<br>Vertebral Body Replacement<br>System<br>K112496 | Zyston Strut Open Titanium<br>Spacer System<br>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<br>Inserters | Fortilink IBF System with<br>TETRAfuse 3D Technology<br>K163673, K172343, and K190498 | T-Plus/Pioneer Interbody Fusion,<br>Vertebral Body Replacement<br>System<br>K112496 | Zyston Strut Open Titanium<br>Spacer System<br>K171495 | |
| | intended to be used with an FDA- | cleared for the implanted level. | Lumbar IB's are also intended for…