ChoiceSpine Stealth Cervical Spacer System

K183397 · Choicespine, LP · ODP · Mar 6, 2019 · Orthopedic

Device Facts

• Record ID: K183397
• Device Name: ChoiceSpine Stealth Cervical Spacer System
• Applicant: Choicespine, LP
• Product Code: ODP · Orthopedic
• Decision Date: Mar 6, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in sketally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

Device Story

Stealth™ Cervical Spacer System is an intervertebral body fusion device; used for anterior cervical spine fusion. Implants feature hollow oval design with superior/inferior angled ridges (teeth) to resist migration; available in various heights/lordotic angles. Implants placed in disc space to facilitate fusion; requires supplemental fixation and bone graft (autogenous/allogenic). Used by surgeons in clinical settings. Device updates include addition of titanium alloy (Ti-6Al-4V ELI) implants and sterile packaging. Benefits include stabilization of spinal segment to treat degenerative disc disease.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical property comparisons and sterilization validation.

Technological Characteristics

Implants: PEEK-OPTIMA (ASTM F2026) or Ti-6Al-4V ELI (ASTM F3001, Class C) with tantalum markers (ASTM F560). Instruments: 455/465 SS (ASTM A564) and 17-4 SS (ASTM F899). Form factor: hollow oval spacer with angled ridges. Sterilization: Gamma radiation (implants, sterile); steam sterilization (instruments, non-sterile).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) requiring anterior cervical intervertebral body fusion at one level (C2-C3 to C7-T1) after 6 weeks of failed non-operative treatment. DDD defined as discogenic neck pain with radiographic degeneration. Must be used with supplemental fixation and autogenous/allogenic bone graft.

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

• Choice Spine Cervical Interbody Spacer System (K091531)
• Choice Spine Tiger Shark System (K172816)
• NuVasive Modulus-C Interbody System (K172676)

Submission Summary (Full Text)

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March 6. 2019

ChoiceSpine, LP Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37922

Re: K183397

Trade/Device Name: ChoiceSpine Stealth™ Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 5, 2019 Received: February 6, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K183397

#### Device Name

ChoiceSpine Stealth™ Cervical Spacer System

#### Indications for Use (Describe)

The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in sketally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 7. 510(k) Summary

| Date | February 5, 2019 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | ChoiceSpine, LP<br>400 Erin Drive<br>Knoxville, TN 37919 |
| Phone | 865-246-3333 |
| Fax | 865-246-3334 |
| Contact Person | Kim Finch, Director of Regulatory Affairs |
| Proposed Proprietary<br>Trade Name | ChoiceSpine Stealth™ Cervical Spacer System |
| Product Class | Class II |
| Classification Name | ChoiceSpine Stealth™ Cervical Spacer System<br>888.3080 - Spinal Intervertebral Body Fusion Device<br>● |
| Device Product Code | ChoiceSpine Stealth™ Cervical Spacer System:<br>ODP |
| Purpose of<br>Submission | The purpose of this submission is to gain clearance for the updated ChoiceSpine<br>Stealth™ Cervical Spacer System. Updates to the system include new material and<br>manufacturing (Ti-6Al-4V ELI per ASTM F3001 Class C), how supplied (sterile packed),<br>and the addition of allogenic bone graft. |
| Device Description | The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape<br>with a hollow center for placement of bone graft. The superior and inferior surfaces<br>have angled ridges, or "teeth," for resisting migration. The spacers are available in an<br>assortment of heights and in multiple angles of lordosis to accommodate different<br>anatomic requirements. |
| Indications for Use | The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical<br>spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1<br>disc for the treatment of degenerative disc disease (DDD) in skeletally mature<br>patients who have had six (6) weeks of non-operative treatment. DDD is defined as<br>neck pain of discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies. The STEALTH™ Cervical Spacer System is to be used with<br>supplemental fixation and with autogenous bone graft and/or allogenic bone graft<br>comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion. |

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## The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 455/465 SS per ASTM A564 and 17-4 SS per ASTM F899.

Primary predicate: Choice Spine Cervical Interbody Spacer System (K091531), Predicate Device Additional Predicate: Choice Spine Tiger Shark System (K172816) Additional Predicate:NuVasive Modulus-C Interbody System (K172676)

The implants proposed in this submission are similar to the predicate devices in Substantial principle of operation, indications for use, stabilization method, anatomic location Equivalence Conclusion and approach, product code and classification, and biocompatibility. The indications for use were compared; the differences include the primary predicate is cleared for use with autograft while the subject device and additional predicate are intended to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. The addition of the allogenic bone graft material does not alter the device intended use.

> The additional spacer proposed made of Titanium (Ti-6Al-4V ELI per ASTM F3001, Class C) is identical in geometry and footprint as the PEEK spacer offered in the Stealth Cervical Spacer System. The only difference between the spacers is the material and manufacturing method which are shared with the additional predicate. The difference between the mechanical properties confirmed that the PEEK spacer is the worst-case compared to the Titanium spacer which is previously tested and cleared under K091531.

> The subject device and additional predicate are both provided sterile while the primary predicate is provided non-sterile. ChoiceSpine's sterilization process has been validated through gamma validation and distribution testing and the results demonstrate that the predetermined acceptance criteria were met. The minimum radiation dose of 25kGy was sufficient to meet a sterilization assurance level (SAL) of 10 ° and the package system remained intact while also maintaining the hermetic barrier.