Elite Expandable Interbody Fusion Device

K162879 · Spineology, Inc. · MAX · Jan 30, 2017 · Orthopedic

Device Facts

• Record ID: K162879
• Device Name: Elite Expandable Interbody Fusion Device
• Applicant: Spineology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment. Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Story

Elite™ Expandable Interbody Fusion Device is a spinal implant system used for lumbar intervertebral body fusion. The device consists of titanium alloy cages with ridges/teeth to resist migration and internal cavities for bone graft packing. It is implanted by a surgeon in an OR setting. The device is designed to be used with autograft/allograft bone and supplemental fixation systems. By providing structural support and facilitating fusion, the device aims to alleviate back pain associated with degenerative disc disease. The system includes specific surgical instrumentation for implantation.

Clinical Evidence

Bench testing only. Mechanical testing performed per FDA Class II Special Controls Guidance and ASTM standards, including static/dynamic axial compression, subsidence, compression shear, expulsion, and static torsion. Bacterial endotoxin testing conducted per ANSI/AAMI ST-72:2011.

Technological Characteristics

Material: Medical grade titanium alloy (Ti-6AL-4V, ELI). Design: Expandable cage with ridges/teeth for fixation and bone graft cavities. Standards: ASTM F2077, ASTM F2267. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six 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

• Elite™ Interbody Fusion Device (K133459)
• Rampart™ O Lumbar Interbody Fusion Device (K160906)
• Rampart™ T Lumbar Interbody Fusion Device (K160906)
• Rampart™ A Lumbar Interbody Fusion Device (K160906)
• Caliber® Spacer (K102293)
• Opticage® Expandable Interbody Fusion Device (K113527)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2017

Spineology Inc. Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul. Minnesota 55127

Re: K162879

Trade/Device Name: Elite™ Expandable Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2016 Received: December 22, 2016

Dear Ms. Hauge:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K162879

#### Device Name

Elite™Expandable Interbody Fusion Device

### Indications for Use (Describe)

Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment.

Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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

| <div><span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-----------------------------------------------------------------------------------------------|
| <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

| Date Prepared: | December 21, 2016 | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Submitter: | Spineology Inc.<br>7800 3rd Street North, Suite 600<br>Saint Paul, MN 55128<br>Establishment Registration Number: 2135156 | | | |
| Contact Person: | Jacqueline A. Hauge<br>Regulatory Affairs Manger<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] | | | |
| Device Name and Classification | | | | |
| Trade Name: | Elite™ Expandable Interbody Fusion Device | | | |
| Common Name: | Spinal implant | | | |
| Classification Name: | Intervertebral body fusion device | | | |
| Product Codes: | MAX | | | |
| Regulatory Class: | Class II | | | |
| Regulation Number: | 21 CFR 888.3080 | | | |

Orthopedic

| Predicate Devices<br>Primary: | K133459 | Elite™ Interbody Fusion Device (Innova Spinal Technologies, LLC) |
|-------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional: | K160906 | Rampart™ O Lumbar Interbody Fusion Device (Spineology Inc.);<br>Rampart™ T Lumbar Interbody Fusion Device (Spineology Inc.);<br>Rampart™ A Lumbar Interbody Fusion Device (Spineology Inc.) |
| | K102293 | Caliber® Spacer (Globus Medical Inc.) |
| | K113527 | Opticage® Expandable Interbody Fusion Device (Interventional Spine, Inc.) |

### I. Purpose

Panel:

The purpose of this submission is to obtain FDA clearance of the Spineology Elite™ Expandable Interbody Fusion Device which is comprised of 10mm and 12mm Elite™ Expandable implantable devices and associated surgical instrumentation.

### II. Previous Submissions

| 510(k) # | Device Name | Purpose of 510(k) |
|----------|---------------------------------------|-------------------|
| K133459 | 12mm Elite™ Interbody Fusion Device | Initial Clearance |
| K150954 | 12mm Elite™ L Interbody Fusion Device | Added Device |

No previous submissions have been submitted for the 10mm Elite™ Expandable device.

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## 510(k) Summary

## III. Device Description

The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.

### IV. Indications for Use

Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Elite™ Expandable implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

### V. Technological Characteristics

Elite™ Expandable implants have the same technological characteristics as the predicate Elite Interbody Fusion Device, including design, intended use, material composition, and function.

### VI. Non-Clinical Testing

The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:

### ASTM F2077

- ASTM F2267 • Static and Dynamic Axial Compression · Subsidence • Static and Dynamic Compression Shear
- Expulsion • Static Torsion

Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

### VII. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Elite™ Expandable Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.