HARRIER-SA™ Lumbar Interbody System

K180519 · Choicespine, LP · OVD · May 16, 2018 · Orthopedic

Device Facts

• Record ID: K180519
• Device Name: HARRIER-SA™ Lumbar Interbody System
• Applicant: Choicespine, LP
• Product Code: OVD · Orthopedic
• Decision Date: May 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

Device Story

Lumbar interbody fusion system; stand-alone intervertebral spacer; used for degenerative disc disease and spondylolisthesis. Device consists of PEEK-OPTIMA HA Enhanced or titanium spacer, four bone screws, and anterior cover plate. Implanted by surgeons in clinical/OR setting to facilitate spinal fusion. Provides mechanical stabilization of vertebral segments; requires autogenous or allogenic bone graft for fusion. Supplemental fixation required for implants ≥20° or when using fewer than four screws. Anterior cover plate mandatory for all implantations. Benefits patient by restoring disc height and promoting fusion in symptomatic lumbar spine.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included static and dynamic compression, static and dynamic compression shear, expulsion, and subsidence testing per ASTM F2077 and ASTM F2267.

Technological Characteristics

Spacer materials: Invibio PEEK-OPTIMA HA Enhanced and Ti-6Al-4V ELI Titanium (ASTM F3001 Class C). Plate/screws: Ti-6Al-4V ELI (ASTM F136). Tantalum markers (ASTM F560). Instruments: 455 SS, 17-4 SS, 465 SS (ASTM A564). Stand-alone interbody fusion system. Sterilization: Implants (except screws) provided sterile; screws and instruments provided non-sterile, steam sterilized by user.

Indications for Use

Indicated for intervertebral body fusion of the lumbar spine (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis, following 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

• Spine Smith Cynch Spinal System - Visualif Interbody Fusion Implant System (K102090)
• NuVasive Lumbar Interbody Implants (K153782)
• Choice Spine TOMCAT™ Cervical Spinal System (K170953)
• Choice Spine TiGer Shark™ (K172816)

Submission Summary (Full Text)

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May 16, 2018

Choice Spine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

## Re: K180519

Trade/Device Name: Choice Spine HARRIER-SA™ Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: April 11, 2018 Received: April 12, 2018

Dear Ms. Finch:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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) K180519

#### Device Name

Choice Spine HARRIER-SA™ Lumbar Interbody System

#### Indications for Use (Describe)

The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

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

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(k) Summary

| Date:<br>Sponsor: | April 9, 2018<br>Choice Spine, LP<br>400 Erin Drive<br>Knoxville, TN 37919 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax:<br>Contact Person: | 865-246-3333<br>865-246-3334<br>Kim Finch, Manager of Regulatory Affairs |
| Proposed<br>Proprietary Trade<br>Name: | Choice Spine HARRIER-SA™ Lumbar Interbody System |
| Product Class:<br>Classification<br>Name: | System Class II |
| | 888.3080 - Intervertebral Body Fusion Device |
| Device Product<br>Code: | OVD, MAX |
| | Purpose of Submission: The purpose of this submission is to gain clearance for the new the Choice Spine<br>HARRIER-SA™ Lumbar Interbody System. |
| Device Description: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various<br>sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-<br>SA™ Lumbar Interbody System is a stand-alone device intended to be used with<br>(4) bone screws provided and the accompanying anterior cover plate assembly.<br>The implant spacer components are made from two materials:<br>Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM<br>F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate<br>and screws per ASTM F136. |
| | The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone<br>device intended to be used with four bone screws and the accompanying<br>anterior cover plate. Supplemental fixation, cleared by the FDA for use in the<br>lumbosacral spine, must be used with implants ≥20°. Supplemental fixation<br>must also be used whenever fewer than four bone screws are used. The<br>anterior cover plate must be utilized whenever the device is implanted. |
| Indications for Use: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for<br>intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally<br>mature patients who have had six months of non-operative treatment. This<br>device is intended for use at either one level or two contiguous levels for the<br>treatment of degenerative disc disease (DDD) with up to Grade I<br>spondylolisthesis. DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies. This<br>device is designed to be used with autogenous bone graft and/or allogenic bone<br>graft comprised of cancellous and/or corticocancellous bone graft. |
| Materials: | The implant spacer components are made from two materials:<br>1.Invibio PEEK-OPTIMA™ HA Enhanced<br>2.Ti-6Al-4V ELI Titanium per ASTM F3001, Class C<br>Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per<br>ASTM F136. All implants except for the screws will be provided sterile. Screws<br>will be provided non-sterile but will be steam sterilized before use.<br><br>Instruments will be provided non-sterile but will be steam sterilized before use.<br>The instrumentation is made from 455 SS and 17-4 SS, 465 SS per ASTM A564. |
| Non-Clinical Testing: | Static Compression - Per ASTM F2077<br>Static Compression Shear - Per ASTM F2077<br>Dynamic Compression - Per ASTM F2077<br>Dynamic Compression Shear - Per ASTM F2077<br>Expulsion<br>Subsidence - per ASTM F2267 |
| Substantial<br>Equivalence: | The implants included in this submission are equivalent to the Spine Smith<br>Cynch Spinal System - Visualif Interbody Fusion Implant System (K102090,<br>primary predicate), NuVasive Lumbar Interbody Implants (K153782, additional<br>predicate), Choice Spine TOMCAT™ Cervical Spinal System (K170953, additional<br>predicate), and the Choice Spine TiGer Shark™ (K172816, additional predicate). |
| Substantial<br>Equivalence<br>Conclusion" | The implants proposed in this submission are similar to the predicate devices in:<br>principle of operation, material, indications for use, biocompatibility,<br>manufacturing and post-processing steps, stabilization method, sterilization<br>method, anatomic location and approach, product code and classification. The<br>indications for use were compared, the differences include the subject device is<br>designed to use four screws for stabilization while the primary predicate utilizes<br>two and is cleared for use with autograft while the subject device and other<br>predicates are intended to be used with autogenenous bone graft and /or<br>allogenic bone graft comprised of cancellous and/or corticocancellous bone<br>graft.<br><br>Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™<br>Lumbar Interbody System design is equivalent when compared to the predicate<br>devices. After considering all similarities and differences to the predicate<br>devices, the subject device has shown to be equivalent when compared to the<br>predicate devices in safety, effectiveness, and performance. |

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