← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K191367 # Harrier-SA Lumbar Interbody System (K191367) _Choice Spine, LLC · MAX · Jul 5, 2019 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191367 ## Device Facts - **Applicant:** Choice Spine, LLC - **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md) - **Decision Date:** Jul 5, 2019 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ChoiceSpine Harrier-SATM 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 non-operative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) 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 ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. 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. ## Device Story Lumbar interbody fusion system; stand-alone device for L2-S1 stabilization. Implant spacer components (PEEK-OPTIMA HA Enhanced or Ti-6Al-4V ELI Titanium) inserted into intervertebral space; secured with four bone screws. Designed for use with autogenous or allogenic bone graft. Used by surgeons in clinical settings to treat degenerative disc disease and Grade I spondylolisthesis. Modification allows optional use of anterior coverplate components. Provides mechanical stability to facilitate spinal fusion; benefits patients by reducing back pain associated with discogenic degeneration. ## Clinical Evidence Bench testing only. Performed static/dynamic compression and compression shear per ASTM F2077, and subsidence per ASTM E2267 to demonstrate mechanical equivalence. ## Technological Characteristics Materials: PEEK-OPTIMA HA Enhanced, Ti-6Al-4V ELI Titanium (ASTM F3001), Tantalum markers (ASTM F560), 455/17-4/465 SS (ASTM A564) for instruments. Stand-alone interbody fusion system with bone screws. Sterilization: Steam sterilization for non-sterile components; others provided sterile. ## Regulatory 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 - ChoiceSpine Harrier-SA Lumbar Interbody System ([K180519](/device/K180519.md)) - Titan Spine Endoskeleton®TAS Interbody Fusion Device / Endoskeleton® TAS Hyperlordotic Interbody Fusion Device ([K163269](/device/K163269.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37922 Re: K191367 Trade/Device Name: Harrier-SATM Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 6, 2019 Received: June 7, 2019 Dear Kim 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's July 5, 2019 {1}------------------------------------------------ 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use #### 510(k) Number (if known) #### K191367 #### Device Name ChoiceSpine Harrier-SATM Lumbar Interbody System ### Indications for Use (Describe) The ChoiceSpine Harrier-SATM 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 non-operative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) 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 ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. 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. > 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 infonmation unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary | Date:
Sponsor: | May 21, 2019
ChoiceSpine, LLC
400 Erin Drive
Knoxville, TN 37919 | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone:
Fax:
Contact Person: | 865-246-3333
865-246-3334
Kim Finch, Director of Regulatory Affairs | | Proposed
Proprietary Trade
Name: | ChoiceSpine Harrier-SA™ Lumbar Interbody System | | Product Class: | Class II | | Classification
Name: | ChoiceSpine Harrier-SA™ Lumbar Interbody System
888.3080 - Spinal Intervertebral Body Fusion Device
• | | Device Product
Code: | ChoiceSpine Harrier-SA™ Lumbar Interbody System
•
MAX | | Purpose of Submission: | The purpose of this submission is to modify the surgical technique guide (STG)
to make the use of the anterior components optional for the Harrier-SATM
Lumbar Interbody System. The intended use remains the same. | | Device Description: | The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various
sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-
SA™ Lumbar Interbody System is a stand-alone device intended to be used with
(4) bone screws. The implant spacer components are made from two materials:
Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6AI-4V ELI Titanium per ASTM
F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6AI-4V ELI plate
and screws per ASTM F136. | | Indications for Use: | The Choice Spine HARRIER-SAT™ 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 non-operative treatment. This
device is intended for use at either one level or two contiguous levels for the
treatment of degenerative disc disease (DDD) 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. 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. | | Materials: | The implant spacer components are made from two materials:
1.Invibio PEEK-OPTIMA™ HA Enhanced
2.Ti-6Al-4V ELI Titanium per ASTM F3001, Class C
Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per
ASTM F136. All implants except for the screws and plates will be provided
sterile. Screws and plates will be provided non-sterile but will be steam
sterilized before use. | | | Instruments will be provided non-sterile but will be steam sterilized before use.
The instrumentation is made from 455 SS and 17-4 SS, 465 SS per ASTM A564. | | Non-Clinical Testing: | Static Compression - Per ASTM F2077
Static Compression Shear - Per ASTM F2077
Dynamic Compression - Per ASTM F2077
Dynamic Compression Shear - Per ASTM F2077
Expulsion - N/A
Subsidence - per ASTM E2267 | {4}------------------------------------------------ Summary of technological characterstics of the subject and predicate(s): The implants proposed in this submission are similar to the predicate devices in: principle of operation, material, indications for use, biocompatibility, manufacturing and post-processing steps, stabilization method, sterilization method, anatomic location and approach, product code and classification. The indications for use were compared, the difference includes the subject device is designed for use without an accompanying coverplate. However, this embodiment is similar to the additional predicate in omitting coverplate utilization. The subject device is identical to the ChoiceSpine Harrier-SA predicate aside from the required utilization of a coverplate. Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices. Dynamic Compression Shear testing of the worst-case implant construct is the standardized test that was determined to most aggressively challenge the functional performance of the device without the additional coverplate. Testing results confirm that utilization of the Harrier SA interbody and screws with or without usage of the coverplate results in equivalent functional performance. After considering all similarities and differences to the predicate devices, the subject device has shown to be equivalent when compared to the predicate devices in safety, effectiveness, and performance. - The implants included in this submission are equivalent to the ChoiceSpine Conclusion: Harrier-SA Lumbar Interbody System (K180519, primary predicate), Titan Spine Endoskeleton®TAS Interbody Fusion Device / Endoskeleton® TAS Hyperlordotic Interbody Fusion Device (K163269, additional predicate). --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191367](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191367) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com