Cervical Spacer

K182477 · Additive Implants, LLC · ODP · Jan 28, 2019 · Orthopedic

Device Facts

• Record ID: K182477
• Device Name: Cervical Spacer
• Applicant: Additive Implants, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jan 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer 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 bone to facilitate fusion.

Device Story

Cervical Spacer is an additively manufactured interbody fusion device; keystone shape with open architecture. Used in anterior cervical spine surgery to facilitate fusion at multiple contiguous levels (C2-T1). Implants are packed with autogenous or allogeneic cancellous bone graft. Requires supplemental fixation; hyperlordotic implants (≥10°) mandate use of an anterior cervical plate. Device provides structural support to the intervertebral space to promote bone growth and spinal stability. Used by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic compression, static torsion), ASTM F2267 (subsidence), and ASTM draft standard (expulsion). Surface evaluation per ASTM F1978. Bacterial endotoxin testing performed per AAMI ST72:2011. No clinical data provided.

Technological Characteristics

Additively manufactured interbody device; material: Ti-6Al-4V ELI titanium alloy (ASTM F3001, Grade 23). Keystone geometry with open architecture. Provided sterile. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with cervical disc degeneration or spinal instability (confirmed by imaging) causing radiculopathy or pain at C2-T1 levels, 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

• Cascadia Interbody System (K160125)
• ALTA Anterior Cervical Interbody Spacer (K173324)
• Novel System (K081730)
• MC+ (K091088)
• BAK/C Interbody Fusion System (P980048)
• SynCage-C (K024364)

Submission Summary (Full Text)

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August 4, 2021

Additive Implants, LLC % Karen Warden, Ph.D. President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026

Re: K182477

Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP

Dear Dr. Warden:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on January 28, 2019. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, [phone], [e-mail].

Sincerely,

Brent Showalter -S

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Additive Implants, LLC % Karen Warden President BackRoads Consulting 12520 Heath Road Chesterland, Ohio 44026

Re: K182477

Trade/Device Name: Cervical Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 27, 2018 Received: December 27, 2018

Dear Karen 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 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 (QS) 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,

## David Hwang -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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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

## Indications for Use

510(k) Number (if known)

K182477

Device Name Cervical Spacer

Indications for Use (Describe)

The Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer 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 bone to facilitate fusion.

| Type of Use (Select one or both, as applicable) | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <table><tr><td><span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span></td><td><span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span></td></tr></table> | <span> <label><input checked="true" 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> |
| <span> <label><input checked="true" 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: | 27 December 2018 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Additive Implants, LLC<br>3101 E. Shea Blvd, Suite 114<br>Phoenix, AZ 85028<br>Office: 602.795.8850<br>Fax: [phone] |
| Sponsor Contact: | Jeff Horn, Vice-President of Commercialization |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc.<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Proposed Trade Name: | Cervical Spacer |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Regulation Names,<br>Regulation Numbers,<br>Product Codes: | Intervertebral fusion device with bone graft, 888.3080, cervical, ODP |
| Device Description: | The Cervical Spacer is an additively manufactured interbody device. These<br>cervical implants have basic keystone shape and an open architecture. A<br>variety of height, length, width and anteroposterior angulation combinations<br>are available to accommodate the anatomic requirements of individual<br>patients. The Cervical Spacers are provided sterile only. |
| Indications for Use: | The Cervical Spacer is intended for anterior intervertebral body fusion in<br>skeletally mature patients who have had at least six weeks of non-operative<br>treatment. The Cervical Spacer is indicated to treat cervical disc<br>degeneration and/or cervical spinal instability, as confirmed by imaging<br>studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy,<br>and/or pain at multiple contiguous levels from C2 - T1. The Cervical Spacer<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 Cervical Spacer implants are manufactured from Ti-6Al-4V ELI titanium<br>alloy (ASTM F3001, Grade 23). |
| Primary Predicate: | Cascadia Interbody System (K2M Inc. - K160125) |
| Additional Predicates: | ALTA Anterior Cervical Interbody Spacer (Astura Medical - K173324),<br>Novel System (Alphatec Spine Inc. - K081730), MC+ (LDR Holding -<br>K091088), BAK/C Interbody Fusion System (Centerpulse - SpineTech, Inc.<br>- P980048), SynCage-C (Synthes Spine – K024364) |
| Performance Data: | Mechanical testing of the worst case Cervical Spacer included static and<br>dynamic compression and static torsion according to ASTM F2077. In<br>addition, the subsidence properties were evaluated according to ASTM<br>F2267 and expulsion according to the ASTM draft standard. The<br>manufactured surface was evaluated according to ASTM F1978.<br>The mechanical test results demonstrate that the Cervical Spacer<br>performance is substantially equivalent to the predicate devices.<br>In addition, bacterial endotoxin testing was conducted in accordance with<br>AAMI ST72:2011 and met the specified testing limit. |
| Technological<br>Characteristics: | The Cervical Spacer possesses the same technological characteristics as<br>one or more of the predicate devices. These include:<br>• intended use (as described above)<br>• basic design (additively manufactured structure),<br>• material (titanium alloy) and<br>• sizes (dimensions are comparable to those offered by the predicate<br>systems)<br>The Cervical Spacer is the same as previously cleared devices. |
| Conclusion: | The Cervical Spacer possesses the same intended use and technological<br>characteristics as the predicate devices. Therefore the Cervical Spacer is<br>substantially equivalent for its intended use. |

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