(29 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not data analysis or image processing.
Yes
The device is an internal fixation device for spinal surgery, intended to treat various spinal conditions as an adjunct to fusion, which directly aligns with the definition of a therapeutic device.
No
The Zenius™ Spinal System is an internal fixation device intended for surgical use (e.g., spinal fusion), not for diagnosing conditions.
No
The device description explicitly lists hardware components (rods, pedicle screw assemblies, etc.) made of Ti6Al4V ELI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like rods, screws, and assemblies, which are typical of surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device is used for fixation within the body, not for testing samples outside the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medyssey Co, Ltd. Zenius Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Zenius™ System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle screw assemblies, compression retaining assemblies, set screws and transverse-link assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients. Subject screws are manufactured from Ti6Al4V ELI per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle fixation
Indicated Patient Age Range
skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is supported by the results of mechanical testing. Performance testing to support justification of safety and effectiveness compared to the predicate include evaluation of: static compression bending, static torsion, static tension, and dynamic compression bending as per ASTM F1717. Results support that modifications to the Zenius™ system screws did not introduce a worst-case scenario and the subject device performs as well or better than the predicate system screw.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093104, K103272, K121670, K171526
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
August 24, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medyssey USA, Inc. % Kyle Kovach Sr. Quality and Regulatory Engineer JALEX Medical 27865 Clemens Road, Suite #3 Westlake, Ohio 44145
Re: K232218
Trade/Device Name: Zenius™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 26, 2023 Received: July 26, 2023
Dear Kyle Kovach:
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
1
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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.08.24
14:47:33 -04'00'
for
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) K232218
Device Name Zenius™ Spinal System
Indications for Use (Describe)
The Medyssey Co, Ltd. Zenius Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
| 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/1 description: The image shows the word "Medyssey" in a dark blue font. Underneath the word are three curved lines in a lighter blue color. The lines are arranged in a way that they appear to be emanating from the word "Medyssey". The overall design is simple and clean, with a focus on the text and the curved lines.
Special 510(k) Summary
| Applicant: | Medyssey USA, Inc.
43176 Business Park Drive
Suite 107
Temecula, CA 92590 USA |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3008692185 |
| Date: | 07/26/2023 |
| Contact Person:
Contact Email:
Contact Telephone: Contact
Fax: | Kyle Kovach, Senior Quality and Regulatory Engineer
kkovach@jalexmedical.com
(440) 787-5832
(440) 933-7839 |
| Device Trade Name: Device
Common Name:
Classification Name:
Device Class:
Reviewing Panel: Regulation
Number: Classification
Product Code: | Zenius™ Spinal System
Thoracolumbosacral Pedicle Screw System
Thoracolumbosacral Pedicle Screw System
II
Orthopedic
888.3070
NKB |
| Primary Predicate Device: | Medyssey USA, Inc. Zenius™ System (K093104) |
| Additional Predicates: | Medyssey USA, Inc. Zenius™ System (K103272)
Medyssey USA, Inc. Medyssey Cannulated Pedicle
Screw (K121670)
Medyssey USA, Inc. Zenius™, Iliad™, and Kora™
Spinal Fixation Systems (K171526) |
Device Description:
The Zenius™ System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle screw assemblies, compression retaining assemblies, set screws and transverse-link assemblies. Various forms and sizes of these implants are available so that adaptations can be utilized to account for the unique pathology of individual patients. Subject screws are manufactured from Ti6Al4V ELI per ASTM F136.
Indications for Use:
The Medyssey Co. Ltd. Zenius™ Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
4
Image /page/4/Picture/1 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 stylized underline. The overall impression is a clean and professional logo or branding element.
Description of Modifications:
The Medyssy Zenius™ System is an updated version of a legally maked of the ever. The period. This submission is for and addition of fenestration to the screw body designs. There were no changes to material or sterilization parameters.
Summary of Technological Characteristics:
The Zenius™ System subject has the same intended use and fundamental scientific technology as the predicate devices. Table 1 below outlines a tabular comparison of the modified device and the evaluate any differences in characteristics and features that may impact safety or effectiveness.
| Subject Device | Primary Predicate Device | Additional Predicates | Comparison | |
|---|---|---|---|---|
| Trade Name | • Zenius™ Spinal System | |||
| -Zenius Pedicle Screws | ||||
| -Zenius II Pedicle Screws | ||||
| -Hedjet Screws | ||||
| -Hedjet Cannulated Poly-Axial | ||||
| Screws | ||||
| -Long Reduction Hole Poly- | ||||
| Axial Cap Screw | ||||
| -Hedjet Hole Poly-Axial | ||||
| Screws | • Zenius™ Spinal System | |||
| -Zenius Pedicle Screws | • Zenius™ Spinal System | |||
| -Zenius Pedicle Screws | Equivalent | |||
| Manufacture | ||||
| r | Medyssey Co. Ltd. | Medyssey Co. Ltd. | Medyssey Co. Ltd. | Equivalent |
| Classification | ||||
| Name | Thoracolumbosacral Pedicle | |||
| Screw System | Thoracolumbosacral Pedicle | |||
| Screw System | Thoracolumbosacral Pedicle Screw | |||
| System | Equivalent | |||
| 510(k) | ||||
| Number | n/a | K093104 | ||
| K103272 | K121670 | |||
| K171526 | N/A |
Table 1: Comparison of Subject and Predicate Device
5
Image /page/5/Picture/1 description: The image shows the word "Medyssey" in a blue, sans-serif font. There are three curved lines in a lighter shade of blue underneath the word. The lines appear to be stylized waves, adding a visual element to the logo.
| Subject Device | Primary Predicate Device | Additional Predicates | Comparison | |
|---|---|---|---|---|
| Product Code | NKB | NKB | NKB | Equivalent |
| Regulation | ||||
| Number | 888.3070 | 888.3070 | 888.3070 | Equivalent |
| Regulation | ||||
| Medical | ||||
| Specialty | Orthopedic | Orthopedic | Orthopedic | Equivalent |
| Materials | Titanium Alloy (Ti6AL4V ELI per | |||
| ASTM F136) | Titanium Alloy (Ti6AL4V ELI per | |||
| ASTM F136) | Titanium Alloy (Ti6AL4V ELI per | |||
| ASTM F136) | Equivalent | |||
| Indications | ||||
| for Use | The Medyssey Co. Ltd. Zenius | |||
| Spinal System is intended for | ||||
| posterior, noncervical pedicle | ||||
| fixation as an adjunct to fusion in | ||||
| skeletally mature patients using | ||||
| autograft and /or allograft for the | ||||
| following indications: | ||||
| degenerative disc disease (DDD) | ||||
| (defined as back pain of discogenic | ||||
| origin with degeneration of the | ||||
| disc confirmed by history and | ||||
| radiographic studies); | ||||
| spondylolisthesis; trauma (i.e., | ||||
| fracture or dislocation): spinal | ||||
| stenosis; curvatures (i.e., scoliosis, | ||||
| kyphosis, and / or lordosis); tumor; | ||||
| pseudoarthrosis; and failed | ||||
| previous fusion. | The Medyssey Co, Ltd., Zenius | |||
| Spinal System, a posterior spinal | ||||
| fixation device, indicated for | ||||
| skeletally mature patients | ||||
| receiving fusion by autogenous | ||||
| bone graft with removal of the | ||||
| implants after the attainment of a | ||||
| solid fusion and is intended to | ||||
| provide immobilization and | ||||
| stabilization of spinal segments as | ||||
| an adjunct to fusion in the | ||||
| treatment of the following acute | ||||
| and chronic instabilities or | ||||
| deformities of the thoracic, | ||||
| lumbar, and sacral spine: severe | ||||
| spondylolisthesis (grades 3 and 4) | ||||
| of the L5-S1 vertebra; | ||||
| degenerative spondylolisthesis | ||||
| with objective evidence of | ||||
| neurologic impairment; fracture; | ||||
| dislocation; scoliosis; kyphosis; | The Medyssey Co. Ltd., Zenius, | |||
| Iliad and Kora Spinal Systems are | ||||
| intended for posterior, noncervical | ||||
| pedicle fixation for the following | ||||
| indications: degenerative disc | ||||
| disease (DDD) (defined as back | ||||
| pain of discogenic origin with | ||||
| degeneration of the disc confirmed | ||||
| by history and radiographic | ||||
| studies); spondylolisthesis; trauma | ||||
| (i.e., fracture or dislocation); spinal | ||||
| stenosis; deformities or curvatures | ||||
| (i.e., scoliosis, kyphosis, and/or | ||||
| lordosis); tumor; pseudoarthrosis; | ||||
| and failed previous fusion. | Equivalent to the | |||
| Additional Predicate |
6
Image /page/6/Picture/1 description: The image shows the word "Medyssey" in a blue, sans-serif font. Underneath the word are several curved blue lines that give the impression of waves. The word is the main focus of the image and is positioned at the top.
| Subject Device | Primary Predicate Device | Additional Predicates | Comparison | |
|---|---|---|---|---|
| spinal tumor; and failed previous | ||||
| fusion (pseudarthrosis). | ||||
| Device | ||||
| Description | The Zenius™ Spinal System, | |||
| Internal Fixation Device for Spinal | ||||
| Surgery is comprised of: rods, | ||||
| pedicle screw assemblies, | ||||
| compression retaining assemblies, | ||||
| set screws and transverse-link | ||||
| assemblies. Various forms and | ||||
| sizes of these implants are | ||||
| available so that adaptations can be | ||||
| utilized to account for the unique | ||||
| pathology of individual patients. | ||||
| Subject screws are manufactured | ||||
| from Ti6Al4V ELI per ASTM | ||||
| F136. | The Medyssey Co. Ltd., Zenius™ | |||
| Spinal System is a top-loading | ||||
| posterior spinal fixation system | ||||
| which consists of pedicle screws, | ||||
| rods, set screws, and a transverse | ||||
| (cross) linking mechanism. The | ||||
| Medyssey Co. Ltd., Zenius™ | ||||
| Spinal System implant | ||||
| components are fabricated from | ||||
| titanium ally (Ti-6Al-4V ELI) that | ||||
| conforms to ASTM F136. Various | ||||
| sizes of these implants are | ||||
| available. Specialized instruments | ||||
| made from surgical instrument | ||||
| grade stainless steel are available | ||||
| for the application and removal of | ||||
| the Medyssey Co., Ltd., Zenius™ | ||||
| Spinal System implants. | The Zenius™ Spinal System, | |||
| Internal Fixation Device for Spinal | ||||
| Surgery is comprised of: Rods, | ||||
| Pedicle Screw Assemblies, | ||||
| Compression Retaining Assemblies, | ||||
| and Transverse-Link Assemblies. | ||||
| Various forms and sizes of these | ||||
| implants are available so that | ||||
| adaptations can be utilized to | ||||
| account for the unique pathology of | ||||
| individual patients. | Equivalent to | |||
| Additional Predicate |
These aspects of the subject device were determined to the previous generation of the device as the two systems compare similarly in:
- Technological Characteristics and Intended Use/Indications for Use .
- Device Function/Performance .
- Materials and Manufacturing Processes ●
- Design Features ●
- Post-Processing Procedures, including Sterility and Shelf-Life Characteristics .
7
Image /page/7/Picture/1 description: The image shows the word "Medyssey" in a bold, dark blue font. Underneath the word are three curved, light blue lines that give the impression of movement or waves. The overall design is simple and clean, with a focus on the text and the curved lines.
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing. Performance testing to support justification of safety and effectiveness compared to the predicate include evaluation of: static compression bending, static torsion, static tension, and dynamic compression bending as per ASTM F1717. Results support that modifications to the Zenius™ system screws did not introduce a worst-case scenario and the subject device performs as well or better than the predicate system screw.
Conclusion:
Based on the indications for use, technological characteristics, impact on mechanical performance, and overall comparison with the predicate device, the subject device has demonstrated substantial equivalence.