Who is the manufacturer of AEON-C Stand Alone System?

Huvexel Co. , Ltd. filed the 510(k) submission for AEON-C Stand Alone System (K191477).

What is the FDA product code for AEON-C Stand Alone System?

OVE. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for AEON-C Stand Alone System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AEON-C Stand Alone System?

COALITION® and COALITION AGX® (K083389 and K173115); Vertu, and Vertu Ti-Bond (K122771 and K181837); CASCADIA™ Interbody System (K160125).

Who can help prepare an FDA 510(k) submission like AEON-C Stand Alone System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AEON-C Stand Alone System

K191477 · Huvexel Co. , Ltd. · OVE · Nov 13, 2019 · Orthopedic

Device Facts

Record ID	K191477
Device Name	AEON-C Stand Alone System
Applicant	Huvexel Co. , Ltd.
Product Code	OVE · Orthopedic
Decision Date	Nov 13, 2019
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.

Device Story

AEON-C™ Stand Alone System is an anterior cervical intervertebral fusion device; consists of PEEK or titanium interbodies with titanium alloy locking mechanism; utilizes titanium alloy bone screws for fixation. Designed for surgical implantation via anterior approach to facilitate fusion in patients with degenerative disc disease. Device provides structural support and stabilization at one or two contiguous levels from C2-T1. Surgeon packs device with autograft/allograft bone graft to promote fusion. Multiple footprints, heights, and lordosis options available to accommodate patient anatomy. Benefits include stabilization of spinal segment and promotion of fusion.

Clinical Evidence

Bench testing only. Performance demonstrated via non-clinical mechanical testing in accordance with ASTM F2077 and ASTM F2267, including static and dynamic compression, compression shear, torsion, subsidence, and expulsion testing.

Technological Characteristics

Materials: PEEK and titanium alloy. Components: Interbodies, fixation plates, titanium alloy bone screws. Design: Multiple footprints, heights, and lordosis options. Standards: ASTM F2077, ASTM F2267. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) with radicular symptoms at one or two contiguous levels from C2-T1. Requires at least 6 weeks of non-operative treatment prior to use.

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

COALITION® and COALITION AGX® (K083389 and K173115)
Vertu, and Vertu Ti-Bond (K122771 and K181837)
CASCADIA™ Interbody System (K160125)

Reference Devices

Rexious Spinal Fixation System (K111362)

Related Devices

K223140 — AEON-C Stand Alone System · Dio Medical, Inc. · Dec 20, 2022
K102547 — COROENT INTERLOCK SYSTEM · Nuvasive, Inc. · Feb 7, 2011
K232348 — RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System · MiRus, LLC · Oct 27, 2023
K212266 — FIX-C PEEK Anterior Cervical Interbody System · Jeil Medical Corporation · Dec 21, 2021
K203129 — NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System · Precision Spine, Inc. · Jan 12, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 13, 2019 HUVEXEL Co., Ltd % Milan George Vice President, R&D Dio Medical Corporation 2000 Campus Lane, Suite 200 Eagleville, Pennsylvania 19403 Re: K191477 Trade/Device Name: AEON-C™ Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 15, 2019 Received: October 16, 2019 Dear Mr. 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Brent Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### 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 K191477 Device Name AEON-C™ Stand Alone System Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) 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 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 information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Services (301) 443-6740 EF Page 1 of 1 PSC Publishing {3}------------------------------------------------ ## K191477 ## 510(k) SUMMARY ## HUVEXEL Co., Ltd's AEON-C™ Stand Alone System | Sponsor: | | |----------|--| |----------|--| | Manufacturer | HUVEXEL Co., Ltd. 101-105 Megacenter, SKn Technopark 124 Sagimakgol-ro, Jungwon-gu Seongnam-si Gyeonggi-do, South Korea | |--------------|----------------------------------------------------------------------------------------------------------------------------------| |--------------|----------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Milan George | |------------------|-------------------| | Phone: | 267-737-9496 x102 | | Fax: | 847-795-1079 | | Date: | October 15, 2019 | | Device Name: | AEON-C™ Stand Alone System | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Intervertebral Body Fusion Device, Cervical | | Classification Name: | Intervertebral fusion device with integrated fixation, cervical | | Classification Number: | Class II | | Product Code/Classification: | OVE | | Description: | The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies. | | 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 | K191477 - 510k Summary Page 1 of 2 {4}------------------------------------------------ | | with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data: | Non-clinical testing was performed to demonstrate that the subject AEON-C™ Stand Alone System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077 and ASTM F2267: - Static & Dynamic compression - Static & Dynamic compression shear - Static & Dynamic Torsion - Subsidence - Expulsion The nonclinical tests demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices. | | Predicate Device: | Primary predicate: Globus Medical Inc. – COALITION® and COALITION AGX® (K083389 and K173115) Additional predicates: Spinal Elements, Inc.— Vertu, and Vertu Ti-Bond (K122771 and K181837), and K2M, Inc. - CASCADIA™ Interbody System (K160125) | | Reference Device: | K111362 – Rexious Spinal Fixation System | | Technological Characteristics | The AEON-C™ Stand Alone System was shown to be substantially equivalent and has equivalent technological characteristics to its predicate and reference devices through comparison in areas including design, labeling/intended use, material composition, function, range of sizes, and packaging. | | Performance and SE Determination: | The AEON-C™ Stand Alone System has been demonstrated to be substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s) and demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate. |