Toro-L Interbody Fusion System

K203038 · Integrity Implants, Inc. · MAX · Mar 26, 2021 · Orthopedic

Device Facts

• Record ID: K203038
• Device Name: Toro-L Interbody Fusion System
• Applicant: Integrity Implants, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The Toro-L Interbody Fusion System is intended for use in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

Device Story

Toro-L Interbody Fusion System consists of bi-directional expandable and monolithic intervertebral body fusion devices; used in thoracolumbar spine. Expandable implant features integrated ramps and threaded actuator; inserted in non-expanded form; expanded to desired height/width; locking mechanism secures construct; post-packed with bone graft. Monolithic implant is non-expanding spacer with dual compartments for bone graft. Both designs feature surface protrusions to resist expulsion. Used by surgeons in clinical settings; requires supplemental internal spinal fixation (e.g., pedicle screws). Restores disc height; provides anterior column support; maintains structural stability to facilitate fusion. Benefits patients by addressing symptomatic disc degeneration and spondylolisthesis.

Clinical Evidence

Bench testing only. Testing included static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), wear debris and particle characterization (ASTM F1877), and subsidence (ASTM F2267). Biocompatibility assessment conducted per ISO 10993-1, including cytotoxicity testing per ISO 10993-5.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI per ASTM F136, Ti-6Al-4V per ASTM F2924). Design: Expandable (threaded actuator/locking mechanism) and monolithic configurations. Surface: Protrusions for endplate gripping. Sterilization: Steam sterilization by user (non-sterile delivery).

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at 1-2 levels (T1-S1), including thoracic disc herniation with myelopathy/radiculopathy, or as an adjunct for multilevel degenerative scoliosis. Requires 6 months of failed 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

• Amplify Surgical's DualX LLIF (K181397)
• Nuvasive's AP Expandable XLIF System (K173025)
• Globus Medical's Rise-L Spacers (K113447)
• Medtronic's Capstone-L Spinal System (K123978)
• Integrity Implants' FlareHawk7 Interbody Fusion System (K183184)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

March 26, 2021

Integrity Implants Inc Lauren Kamer Senior Director of Regulatory and Clinical Affairs 354 Hiatt Drive Palm Beach Gardens, Florida 33418

Re: K203038

Trade/Device Name: Toro-L Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: February 19, 2021 Received: February 24, 2021

Dear Lauren Kamer:

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 medical devices and radiation-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,

for

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}------------------------------------------------

# Indications for Use

K203038

Page 1 of 1

510(k) Number (if known)

## K203038

Device Name Toro-L Interbody Fusion System

## Indications for Use (Describe)

The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Toro-L Interbody Fusion System is intended for use in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY

## Toro-L Interbody Fusion System

September 15, 2020

| I. | Company: | | Integrity Im lants Inc.<br>354 Hiatt Drive<br>Palm Beach Gardens, FL 33418<br>Telephone: [phone] |
|------|-------------------------------------------------|-----|---------------------------------------------------------------------------------------------------------------------------------|
| II. | Contact: | mer | Lauren Ka<br>Senior Director of Regulatory and Clinical Affairs |
| III. | Proprietary Trade Name: | | Toro-L Interbody Fusion System |
| IV. | Common Name: | | Intervertebral Body Fusion Device<br>with Bone Graft, Lumbar;<br>Intervertebral Body Fusion Device<br>with Bone Graft, Thoracic |
| V. | Classification Name:<br>Class:<br>Product Code: | | Intervertebral Body Fusion Device (21 CFR 888.3080)<br>II<br>MAX, PHM |

#### Product Description VI.

Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a monolithic interbody fusion device intended for use in the thoracolumbar spine.

Once implanted, the Toro-L interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The Toro-L interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation

{4}------------------------------------------------

instrumentation that has been cleared for use in the lumbar spine. The Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

#### VII. Indications for Use

The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Toro-L Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

#### VIII. Summary of Technological Characteristics

The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.

The Toro-L Interbody Fusion System expandable implant has integrated ramps and a threaded actuator that allow the implant to be inserted in a non-expanded form, and then subsequently expanded to full width and desired height through continuous expansion. When the desired height is achieved, the locking system is engaged to secure the construct in its final expanded configuration. The implant is then post-packed with bone graft.

{5}------------------------------------------------

The monolithic implant is a non-expanding conventional spacer with the interior space of the device divided into two compartments for bone graft containment.

Both the expandable and monolithic configurations have protrusions on the superior and inferior surfaces of the endplates of the implant to grip the adjacent vertebral endplates to resist expulsion.

The subject implant and instruments are offered non-sterile and are intended to be steam sterilized by the user prior to use.

### IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

To demonstrate the substantial equivalence of the subject Toro-L Interbody Fusion System to legally marketed predicate devices, Amplify Surgical's DualX LLIF, K181397 (SE 09/27/2018) is used as the primary predicate device. Additionally, the following devices are being used as predicate devices for this submission:

- . Nuvasive's AP Expandable XLIF System, K173025 (SE 02/08/2018)
- Globus Medical's Rise-L Spacers, K113447 (SE 01/26/2012) ●
- . Medtronic's Capstone-L Spinal System, K123978 (SE 04/09/2013)
- Integrity Implants' FlareHawk7 Interbody Fusion System, K183184 (SE 04/03/2019)

#### X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted

Integrity Implants has conducted bench performance testing in support of this premarket notification submission as follows:

- Static Axial Compression in accordance with ASTM F2077 ●
- . Dynamic Axial Compression in accordance with ASTM F2077
- . Static Compression Shear in accordance with ASTM F2077
- . Dynamic Compression Shear in accordance with ASTM F2077
- Wear Debris and Particle Characterization in accordance with ASTM F1877
- . Subsidence in accordance with ASTM F2267

Integrity Implants has conducted a biocompatibility assessment in accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.

{6}------------------------------------------------

#### XI. Conclusions Drawn for the Non-Clinical and Clinical Tests

Based on the bench performance testing, biocompatibility assessment/testing, and other supporting documentation provided in this premarket notification, the subject Toro-L Interbody Fusion System demonstrates substantial equivalence to legally marketed predicate devices, and any differences between the subject device and the predicate devices do not impact the safety and effectiveness of Toro-L Interbody Fusion System.