SureMAX Family of Cervical Spacers

K193359 · Additive Implants, Inc. · ODP · Jan 3, 2020 · Orthopedic

Device Facts

• Record ID: K193359
• Device Name: SureMAX Family of Cervical Spacers
• Applicant: Additive Implants, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Jan 3, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MR), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

Device Story

SureMAX™ Family of Cervical Spacers are additively manufactured interbody fusion implants; keystone shape; open architecture. Used in anterior cervical spine surgery; requires supplemental fixation (anterior cervical plate for hyperlordotic implants ≥10°). Implants packed with autogenous/allogeneic bone graft to facilitate fusion. Surgeon selects appropriate height, length, width, and angulation based on patient anatomy. Device provides structural support to intervertebral space to promote fusion; benefits patient by stabilizing spinal segment and addressing radiculopathy/pain.

Clinical Evidence

Bench testing only. Evaluated via mechanical testing per ASTM F2077 (static/dynamic compression and torsion) and ASTM F2267 (subsidence and expulsion). Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Additively manufactured interbody fusion device; material: Ti-6Al-4V ELI titanium alloy (ASTM F3001, Grade 23); keystone shape with open architecture; provided sterile; dimensions vary by patient anatomy.

Indications for Use

Indicated for skeletally mature patients with cervical disc degeneration and/or cervical spinal instability (C2-T1) resulting in radiculopathy and/or pain, following at least six weeks 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

• Cervical Spacer (Additive Implants, LLC - K182477)
• Cascadia Interbody System (K2M Inc. – K160125)
• Aleutian IBF System (K2M Inc. - K082698)

Submission Summary (Full Text)

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January 3, 2020

Additive Implants, Inc. % Karen E. Warden, PhD President BackRoads Consulting, Inc. 12520 Heath Road Chesterland, Ohio 44026

Re: K193359

Trade/Device Name: SureMAXTM Family of Cervical Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 3, 2019 Received: December 4, 2019

Dear Dr. Warden:

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

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

Sincerely,

Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

## K193359

Device Name SureMAX™ Family of Cervical Spacers

#### Indications for Use (Describe)

The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MR), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

| Type of Use (Select one or both, as applicable) | <span> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary

| Date: | 3 December 2019 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Additive Implants, Inc. |
| | 3101 E. Shea Blvd, Suite 122 |
| | Phoenix, AZ 85028 |
| | Office: 602.795.8850 |
| | Fax: [phone] |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhD |
| | BackRoads Consulting Inc. |
| | PO Box 566 |
| | Chesterland, OH 44026 |
| | Office: 440.729.8457 |
| Proposed Trade Name: | SureMAX™ Family of Cervical Spacers |
| Common Name: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name,<br>Regulation Number,<br>Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Submission Purpose: | The subject 510(k) adds a new anterior cervical spacer (SureMAX™-X) to<br>the SureMAX™ Family of Cervical Spacers. |
| Device Description: | The SureMAX™ Family of Cervical Spacers is an additively manufactured<br>interbody system. These cervical implants have basic keystone shape and<br>an open architecture. A variety of height, length, width and anteroposterior<br>angulation combinations are available to accommodate the anatomic<br>requirements of individual patients. The SureMAX™ Family of Cervical<br>Spacers is provided sterile. |
| Indications for Use: | The SureMAX™ Family of Cervical Spacers is intended for anterior<br>intervertebral body fusion in skeletally mature patients who have had at<br>least six weeks of non-operative treatment. The SureMAX™ Family of<br>Cervical Spacers is indicated to treat cervical disc degeneration and/or<br>cervical spinal instability, as confirmed by imaging studies (radiographs, CT,<br>MRI), that results in radiculopathy, myelopathy, and/or pain at multiple<br>contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers<br>is to be used with supplemental fixation; the hyperlordotic implants (≥10°)<br>are required to be used with an anterior cervical plate. The implants are<br>designed for use with autogenous and/or allogeneic bone graft comprised of<br>cancellous and/or corticocancellous bone to facilitate fusion. |
| Materials: | The SureMAX™ Family of Cervical Spacers is manufactured from Ti-6Al-4V<br>ELI titanium alloy (ASTM F3001, Grade 23). |
| Primary Predicate: | Cervical Spacer (Additive Implants, LLC - K182477) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. – K160125), Aleutian IBF System<br>(K2M Inc. - K082698) |
| Performance Data: | The modified SureMAX™-X cervical spacer was evaluated via mechanical<br>testing per ASTM F2077 (including static and dynamic compression and<br>static and dynamic torsion), ASTM F2267 (subsidence) and expulsion. The<br>results demonstrated the performance of the modified cervical spacer is<br>substantially equivalent to the predicate. |

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| Technological<br>Characteristics: | The modified SureMAX™-X cervical spacer possesses the same<br>technological characteristics as one or more of the predicate devices. These<br>include:<br>• performance (as described above),<br>• basic design (additively manufactured structural interbody),<br>• material (titanium alloy) and<br>• size (dimensions are comparable to those offered by the cleared<br>devices).<br>Therefore the fundamental scientific technology of the modified<br>SureMAX™-X cervical spacer is the same as previously cleared devices. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The modified SureMAX™-X cervical spacer possesses the same intended<br>use and technological characteristics as the predicate devices. Therefore<br>the modified SureMAX™-X cervical spacer is substantially equivalent for its<br>intended use. |