EVOL Spinal Interbody System, EVOS Lumbar Interbody System
Device Facts
| Record ID | K180891 |
|---|---|
| Device Name | EVOL Spinal Interbody System, EVOS Lumbar Interbody System |
| Applicant | Cutting Edge Spine, LLC |
| Product Code | MAX · Orthopedic |
| Decision Date | May 4, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The EVOL® Spinal Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.
Device Story
The EVOL and EVOS systems are intervertebral body fusion spacers designed for lumbar spinal stabilization. Implants are manufactured from PEEK-OPTIMA (Natural or HA-enhanced) per ASTM F2026, featuring embedded tantalum markers (ASTM F560) for radiographic visualization. Devices are hollow with surface teeth to improve fixation and facilitate bone graft containment. Surgeons implant these devices via posterior, transforaminal, retroperitoneal, or anterior approaches to restore disc height and promote fusion in patients with DDD. The systems include specialized instrumentation for insertion. By providing structural support and maintaining intervertebral spacing, the devices facilitate spinal fusion, potentially reducing discogenic back pain and stabilizing the affected vertebral segments.
Clinical Evidence
Bench testing only. Mechanical performance testing including static compression, static compression shear, dynamic compression, and expulsion testing was performed per ASTM F2026 to demonstrate substantial equivalence.
Technological Characteristics
Materials: PEEK-OPTIMA Natural (LT1) or PEEK-OPTIMA HA Enhanced (LT120) per ASTM F2026; Tantalum markers per ASTM F560. Form factor: Hollow spacers with surface teeth, various lordotic angles/sizes. Connectivity: None. Sterilization: Not specified. Software: None.
Indications for Use
Indicated for skeletally mature patients with lumbar Degenerative Disc Disease (DDD) and up to Grade 1 spondylolisthesis at 1-2 contiguous levels (L2-S1) who failed 6 months of non-operative treatment. Used with autograft/allograft and supplemental fixation.
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
- Cutting Edge Spine Interbody Device (K102957)
- EVOS Lumbar Interbody System (K150321)
- Talos® Intervertebral Body Fusion Devices (K170395)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Cutting Edge Spine, LLC Kyle Kuntz Manager R&D 101 Waxhaw Professional Park. Suite A Waxhaw, North Carolina 28173
Re: K180891
Trade/Device Name: EVOL® Spinal Interbody System. EVOS Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 3, 2018 Received: April 5, 2018
Dear Kyle Kuntz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
May 4, 2018
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
#### K180891
Device Name EVOL® Spinal Interbody System
#### Indications for Use (Describe)
The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOL® Spinal Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</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."
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
#### K180891
Device Name EVOS Lumbar Interbody System
#### Indications for Use (Describe)
The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with 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
"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."
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Image /page/4/Picture/0 description: The image is a logo for Cutting Edge Spine (CES). The logo features a stylized, abstract design above the text. The abstract design consists of three curved lines in different colors: orange, green, and blue. Below the abstract design is the text "CES" in a bold, sans-serif font, with the words "CUTTING EDGE SPINE" written in a smaller font size underneath.
# 510(k) Summary
#### SUBMITTER I.
### Date Prepared: 05/04/2018
Applicant: Cutting Edge Spine, LLC 101 Waxhaw Professional Park Dr., Suite A Waxhaw, NC 28173 Contact Person: Kyle Kuntz, Manager R&D Tel: (704) 243-0892 e-mail: k.kuntz@cuttingedgespine.com
### Application Correspondents:
| Contact Person: | Kyle Kuntz, Manager R&D<br>Tel: (704) 243-0892<br>e-mail: k.kuntz@cuttingedgespine.com |
|--------------------|----------------------------------------------------------------------------------------|
| Alternate Contact: | Shyam Patel, R&D Biomedical Engineer |
| Alternate Contact: | Shyam Patel, R&D Biomedical Engineer |
|--------------------|--------------------------------------|
| Tel: | (704) 243-0892 |
| e-mail: | s.patel@cuttingedgespine.com |
#### II. DEVICE
## a. EVOL® Spinal Interbody System
| Trade Name: | EVOL® Spinal Interbody System |
|-----------------------|-------------------------------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Per 21 CFR as follows:<br>888.3080<br>Intervertebral Fusion Device with Bone Graft, Lumba |
| Regulatory Class: | II |
| Product Codes: | MAX |
### b. EVOS Lumbar Interbody System
| Trade Name: | EVOS Lumbar Interbody System |
|-----------------------|--------------------------------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Per 21 CFR as follows:<br>888.3080<br>Intervertebral Fusion Device with Bone Graft, Lumbar |
| Regulatory Class: | II |
| Product Codes: | MAX |
Image /page/4/Figure/15 description: The image shows three horizontal bars of different colors stacked on top of each other. The top bar is orange, the middle bar is green, and the bottom bar is light blue. The bars are of equal width and appear to be evenly spaced. The background is white, and there is a black bar at the very bottom of the image.
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Image /page/5/Picture/1 description: The image is a logo for Cutting Edge Spine (CES). The logo features three curved lines in orange, green, and blue above the letters CES. Below the letters is the text "CUTTING EDGE SPINE" in a smaller font.
#### III. PREDICATE DEVICES
| | 510(k)<br>Number | Device | Manufacturer |
|-------------------------|------------------|----------------------------------------------|------------------------|
| Primary<br>Predicate | K102957 | Cutting Edge Spine<br>Interbody Device | Cutting Edge Spine |
| Additional<br>Predicate | K150321 | EVOS Lumbar<br>Interbody System | Cutting Edge Spine |
| Additional<br>Predicate | K170395 | Talos® Intervertebral<br>Body Fusion Devices | Meditech Spine,<br>LLC |
#### IV. DEVICE DESCRIPTION
## a. EVOL® Spinal Interbody System
The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA or PEEK-OPTIMA HA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-LIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved. The CES-PLIF and CES-LIF are used in pairs while the other options are used singly or in pairs.
The EVOL® Spinal Interbody System implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The implants themselves are made of biocompatible PEEK-Optima Natural (LT1) or [PEEK-Optima HA Enhanced (LT120) - CES-LIF only] polymer material (per ASTM F2026).
Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).
## b. EVOS Lumbar Interbody System
The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 and PEEK Optima LT120HA per ASTM F-2026, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The
Image /page/5/Figure/12 description: The image shows a simple bar chart with three horizontal bars. The top bar is orange, the middle bar is green, and the bottom bar is light blue. The bars are of similar length, suggesting that the values they represent are close in magnitude.
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Image /page/6/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features a stylized, colorful swirl design in orange, green, and blue above the letters "CES" in a bold, black font. Below the letters, the words "CUTTING EDGE SPINE" are written in a smaller, lighter font.
EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.
The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.
Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.
The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.
The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.
#### V. INDICATIONS FOR USE
## a. EVOL® Spinal Interbody System
The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
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Image /page/7/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features a stylized, curved design in three colors: orange, green, and blue, positioned above the text "CES" in a bold, sans-serif font. Below "CES" is the text "CUTTING EDGE SPINE" in a smaller font size. The logo appears to be professionally designed and is likely used for branding purposes.
The EVOL® Spinal Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.
## b. EVOS Lumbar Interbody System
The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICES
Documentation was submitted which demonstrated that the EVOL® Spinal Interbody System and the EVOS Lumbar Interbody System are substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- FDA product codes ●
- o Indications for Use
- Anatomical Region
- o Implant Materials
- o Product Dimensions
- Device Features ●
- Mechancial Performance ●
- Available by prescription only ●
- Made for single use ●
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Image /page/8/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features a stylized, abstract design above the text "CES" in bold, black letters. Below "CES" is the text "CUTTING EDGE SPINE" in a smaller font size. The abstract design consists of three curved lines in orange, green, and blue, resembling a spine-like shape.
#### NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VII.
## a. EVOL® Spinal Interbody System
Static Compression, Static Compression Shear and Dynamic Compression testing was performed per ASTM F2026. Expulsion testing was also performed. Testing performed showed substantial equivalence to the predicate.
## b. EVOS Lumbar Interbody System
No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
#### CONCLUSIONS VIII.
## a. EVOL® Spinal Interbody System
Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the addition of EVOL® Spinal Interbody System spacers (CES-LIF spacers only) made from LT120 does not raise any new safety or efficacy concerns nor does the addition of allograft comprised of cancellous and/or corticocancellous bone graft to the indications. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.
### b. EVOS Lumbar Interbody System
No design changes were made to the existing devices, nor were any new components added to the system. The indications were expanded to include the use of allograft comprised of cancellous and/or corticocancellous bone graft like the predicate. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.
