AEON-C™ Stand Alone System

K223140 · Dio Medical, Inc. · OVE · Dec 20, 2022 · Orthopedic

Device Facts

• Record ID: K223140
• Device Name: AEON-C™ Stand Alone System
• Applicant: Dio Medical, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Dec 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

Device Story

AEON-C™ Stand Alone System is an anterior cervical intervertebral fusion device; includes PEEK or titanium interbodies; utilizes titanium alloy locking mechanism integrated in anterior fixation plate or within interbody; anchored to patient anatomy via two titanium alloy bone screws. Designed for anterior surgical approach; provides structural support for fusion; packed with autograft/allograft bone graft. Used by surgeons in clinical/OR settings to treat degenerative disc disease. Multiple footprints, heights, and lordosis options available to accommodate patient anatomy. Device provides stabilization to facilitate spinal fusion; benefits patients by alleviating radicular symptoms associated with DDD.

Clinical Evidence

No clinical data. Bench testing not required as the subject device is identical to the previously cleared predicate device (K191477).

Technological Characteristics

Materials: PEEK and titanium alloy. Components: Interbodies, fixation plates, and titanium alloy bone screws. Design: Multiple footprints, heights, and lordosis options. Principle: Stand-alone anterior cervical fusion with integrated locking mechanism. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one or two contiguous levels from C2-T1. Requires 6 weeks of prior non-operative treatment. Contraindicated in patients without skeletal maturity or those not meeting DDD diagnostic criteria.

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

• Huvexel Co. Ltd. - AEON-C™ Stand Alone System (K191477)

Submission Summary (Full Text)

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December 20, 2022

Dio Medical Inc Milan George VP of R&D 2100 Campus LaneSuite 100 East Norriton, Pennsylvania 19403

Re: K223140

Trade/Device Name: AEON-CTM Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 30, 2022 Received: October 4, 2022

Dear Milan George:

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

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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) 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Katherine D. Kavlock -S

for

Brent 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

Enclosure

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# Indications for Use

510(k) Number (if known) K223140

Device Name AEON-C™ Stand Alone System

#### Indications for Use (Describe)

The AEON-C™ Stand Alone System is a stand-alone anterior cervical fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral intervertebral fusion device.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY

### Dio Medical AEON-C™ Stand Alone System

| Sponsor: | Manufacturer: | Dio Medical Corp.<br>2100 Campus Lane, Suite 100<br>East Norriton, PA 19403 |
|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact:<br>Email:<br>Phone: | Milan George<br>[e-mail]<br>1-877-394-5407 ext.102 |
| Date Prepared: | September 30, 2022 | |
| Device Name: | AEON-C™ Stand Alone System | |
| Common Name: | Intervertebral Body Fusion Device, Cervical | |
| Classification<br>Name: | Intervertebral fusion device with integrated fixation, cervical | |
| Classification<br>Number: | 21 CFR 888.3080 | |
| Product Code/<br>Classification: | OVE, Class II | |
| Description: | The AEON-C™ Stand Alone System includes PEEK interbodies and<br>titanium interbodies, which utilize a titanium alloy locking<br>mechanism that is either integrated in an anterior fixation plate or<br>within the interbody. Both PEEK interbodies and titanium<br>interbodies, with or without fixation plates, are to be anchored to<br>patient anatomy via two (2) titanium alloy bone screws. The<br>implant design includes multiple footprints, heights and lordosis<br>options and the screw design includes multiple diameters and<br>lengths, to fit a variety of patient anatomies. | |
| Intended Use: | The AEON-C™ Stand Alone System is a stand-alone anterior cervical<br>intervertebral fusion device indicated for use in skeletally mature<br>patients with degenerative disc disease (DDD) with accompanying<br>radicular symptoms at one or two contiguous levels from C2-T1.<br>DDD is defined as discogenic pain with degeneration of the disc<br>confirmed by history and radiographic studies. The AEON-C™ Stand<br>Alone System should be packed with autograft and/or allograft<br>comprised of cancellous, cortical and/or corticocancellous bone<br>graft and implanted with an anterior approach. | |
| Patients should receive at least six (6) weeks of non-operative<br>treatment prior to treatment with a cervical intervertebral fusion<br>device. | | |
| Predicate<br>Device: | Primary predicate:<br>Huvexel Co. Ltd. - AEON-C™ Stand Alone System (K191477) | |
| Substantial<br>Equivalence: | The AEON-C™ Stand Alone System is identical to the predicate<br>device and is as safe and effective as the Huvexel - AEON-C™ Stand<br>Alone System. The Subject device has the same intended uses and<br>similar indications, technological characteristics, and principles of<br>operation as its predicate device. There are no technological<br>differences between the Subject device and its predicate devices<br>resulting in no K191477 issues of safety or effectiveness. Thus, the<br>Dio Medical- AEON-C™ Stand Alone System is<br>identical/substantially equivalent to the predicates. | |
| Performance<br>Data: | The subject and predicate devices are identical and therefore, no<br>performance testing is required. Submission is only transferring<br>name of a system that has already been cleared under K191477.<br>No testing is required. | |
| Conclusion: | The Dio Medical AEON-C™ Stand Alone System has the same<br>intended uses and similar indications, technological characteristics,<br>and principles of operation as its predicate device. Thus, the<br>subject device is identical/substantially equivalent to the predicate<br>device. | |

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