(32 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions," which are all therapeutic purposes.
No
This device is a surgical implant designed for stabilization of the cervical spine. Its purpose is structural support during fusion development, not to diagnose medical conditions.
No
The device description explicitly states the system consists of physical components manufactured from titanium alloy, including bone plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Athena III Cervical Plate System: The description clearly states that this system is an implantable device used for anterior interbody screw fixation of the cervical spine. It is a surgical implant used to stabilize the spine during fusion.
The intended use, device description, and performance studies all relate to the mechanical and structural properties of the implant for surgical use, not to diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Athena III Cervical Plate System is interior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
Product codes
KWQ
Device Description
The Athena III Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena III Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena III Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, sub-axial cervical spine from C3 through C7 levels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical Testing: A full suite of mechanical testing was performed to evaluate performance of the modifications to the cervical plates and screws in an effort to verify strength and safety. Substantial equivalence is supported by the results of mechanical testing, including static compression bending, static torsion, static tension, and dynamic compression bending as per ASTM F1717.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
March 7, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Medyssey USA, Inc. % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd.. Suite #3 Westlake, Ohio 44145
Re: K230301
Trade/Device Name: Athena III Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 2, 2023 Received: February 3, 2023
Dear Jennifer Palinchik:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known)
K230301
Device Name Athena III Cervical Plate System
Indications for Use (Describe)
The Athena III Cervical Plate System is interior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
| 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 complete 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."
3
Image /page/3/Picture/0 description: The image shows the word "Medyssey" in a serif font. The word is in a dark blue color. Underneath the word are three curved lines in a lighter blue color. The lines appear to be stylized waves.
Special 510(k) Submission -Athena III Cervical Plate System Section VII - 510(k) Summary
Special 510(k) Summary
| Applicant: | Medyssey USA, Inc.
43176 Business Park Drive
Suite 107
Temecula, CA 92590 USA |
|------------------------------------|----------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3008692185 |
| Date: | February 2, 2023 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Email: | jpalinchik@jalexmedical.com |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Athena III Cervical Plate System |
| Device Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3060 |
| Classification Product Code: | KWQ |
| Predicate Device: | Medyssey USA, Inc. Athena II Cervical Plate System
(K183409) |
Device Description:
The Athena III Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena III Cervical Plate System are manufactured from titanium alloy (Ti-6AI-V), as per ASTM F136. The system consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.
Indications for Use:
The Athena III Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
4
Image /page/4/Picture/0 description: The image shows the word "Medyssey" in a dark blue font. Below the word are three curved lines in a lighter blue color. The lines appear to be a design element, possibly representing waves or a stylized underline.
Page 2 of 4 Special 510(k) Submission -Athena III Cervical Plate System Section VII – 510(k) Summary
Description of Modifications:
The Medyssey Athena III Cervical Plate System is an updated 3rd generation version of a legally marketed previous generation of the device, the Athena II Cervical Plate System. The purpose of this submission is for Medyssey to obtain clearance for design changes that include modification of screw design and a modified wing plate design. Table 7.1 below displays a visual comparison of the modified subject device consisting of the cervical plate and screw alongside the predicate device (not to scale). There were no changes to material or sterilization parameters. These changes and relevant risks are discussed in greater detail within this submission.
| Subject Device:
Athena III Cervical
Plate System | Predicate Device:
Athena II Cervical
Plate System |
|--------------------------------------------------------|---------------------------------------------------------|
| Image: Athena III Cervical Plate System and screw | Image: Athena II Cervical Plate System and screw |
Table 7.1: Device Comparison
5
Image /page/5/Picture/0 description: The image shows the word "Medyssey" in a dark blue font. There are three curved lines in a lighter blue color underneath the word. The lines appear to be a design element, possibly representing waves or a similar concept.
Special 510(k) Submission -Athena III Cervical Plate System Section VII – 510(k) Summary
Summary of Technological Characteristics:
The Athena III Cervical Plate System and the predicate have the same intended use and fundamental scientific technology. Table 7.2 below outlines a tabular comparison of the modified device and the predicate Athena II Cervical Plate System to evaluate any differences in characteristics and features that may impact safety or effectiveness.
| Modified Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Trade Name | Athena III Cervical Plate System | Athena II Cervical Plate System | Equivalent |
| Manufacturer | Medyssey | Medyssey | Equivalent |
| Classification | |||
| Name | Spinal Intervertebral Body | ||
| Fixation Orthosis | Spinal Intervertebral Body | ||
| Fixation Orthosis | Equivalent | ||
| 510(k) | |||
| Number | n/a | K183409 | Equivalent |
| Product Code | KWQ | KWQ | Equivalent |
| Regulation | |||
| Number | 888.3060 | 888.3060 | Equivalent |
| Regulation | |||
| Medical | |||
| Specialty | Orthopedic | Orthopedic | Equivalent |
| Materials | Titanium Alloy (Ti6AL4VELI) | Titanium Alloy (Ti6AL4VELI) | Equivalent |
| Indications for | |||
| Use | The Athena Cervical III Plate | ||
| System is intended for anterior | |||
| interbody screw fixation of the | |||
| cervical spine. The system is | |||
| indicated for use in the | |||
| temporary stabilization of the | |||
| anterior spine during the | |||
| development of a solid spinal | |||
| fusion in patients with | |||
| degenerative disc disease (as | |||
| defined by neck pain of | |||
| discogenic origin with | |||
| degeneration of the disc | |||
| confirmed by patient history and | |||
| radiographic studies), trauma | |||
| (including fractures), tumors, | |||
| deformity (defined as kyphosis, | |||
| lordosis, or scoliosis), | |||
| pseudoarthrosis, and/or failed | |||
| previous fusions. The Athena III | |||
| Cervical Plate System can be | |||
| implanted in the sub-axial | |||
| cervical spine from C3 through | |||
| C7 levels. | The Athena II Cervical Plate | ||
| System is intended for anterior | |||
| interbody screw fixation of the | |||
| cervical spine. The system is | |||
| indicated for use in the | |||
| temporary stabilization of the | |||
| anterior spine during the | |||
| development of a solid spinal | |||
| fusion in patients with | |||
| degenerative disc disease (as | |||
| defined by neck pain of | |||
| discogenic origin with | |||
| degeneration of the disc | |||
| confirmed by patient history | |||
| and radiographic studies), | |||
| trauma (including fractures), | |||
| tumors, deformity (defined as | |||
| kyphosis, lordosis, or | |||
| scoliosis), pseudoarthrosis, | |||
| and/or failed previous fusions. | |||
| The Athena II Cervical Plate | |||
| System can be implanted in the | |||
| sub-axial cervical spine from | |||
| C3 through C7 levels. | Equivalent |
Table 7.2: Comparison of Subject and Predicate Device
6
Image /page/6/Picture/1 description: The image shows the word "Medysey" in a bold, sans-serif font. The word is in a dark blue color. Underneath the word are three curved lines, also in dark blue, that appear to be stylized waves. The overall design is simple and clean, with a focus on the text and the wave-like graphic element.
Special 510(k) Submission -Athena III Cervical Plate System Section VII - 510(k) Summary
| Modified Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | |||
| Description | The Athena III Cervical Plate | ||
| System is an anterior cervical | |||
| plating system offered pre- | |||
| lordosed with large graft | |||
| visibility windows intended for | |||
| anterior screw fixation to the | |||
| cervical spine. The components | |||
| of the Athena III Cervical Plate | |||
| System are manufactured from | |||
| titanium alloy (Ti-6Al-4V) as | |||
| described in ASTM F136. The | |||
| Athena III Cervical Plate System | |||
| consists of a variety of shapes | |||
| and sizes of bone plates and | |||
| screws. Implant components are | |||
| anodized per AMS 2487A. | The Athena II Cervical Plate | ||
| System is an anterior cervical | |||
| plating system offered pre- | |||
| lordosed with large graft | |||
| visibility windows intended for | |||
| anterior screw fixation to the | |||
| cervical spine. The components | |||
| of the Athena II Cervical Plate | |||
| System are manufactured from | |||
| titanium alloy (Ti-6Al-4V) as | |||
| described in ASTM F136. The | |||
| Athena II Cervical Plate System | |||
| consists of a variety of shapes | |||
| and sizes of bone plates and | |||
| screws. Implant components are | |||
| anodized per AMS 2487A. | Equivalent |
These aspects of the subject device were determined to be equivalent to the previous generation of the device as the two systems compare similarly in:
- Regulatory Characteristics and Intended Use/Indications for Use
- Device Function/Performance
- Materials and Manufacturing Processes ●
- Design Features/Dimensions
- . Post-Processing Procedures, including Sterility and Shelf-Life Characteristics
Mechanical Testing:
A full suite of mechanical testing was performed to evaluate performance of the modifications to the cervical plates and screws in an effort to verify strength and safety. Substantial equivalence is supported by the results of mechanical testing, including static compression bending, static torsion, static tension, and dynamic compression bending as per ASTM F1717. Results and discussion of the testing is further discussed within the submission.
Conclusion:
Based on the indications for use, technological characteristics, mechanical testing, and overall comparison with the predicate device, the subject device has demonstrated substantial equivalence.