(60 days)
Not Found
No
The device description focuses on the physical components of a spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for posterior, noncervical pedicle fixation as an adjunct to fusion for multiple medical indications, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. Its purpose is to treat or alleviate these conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an internal fixation device for spinal surgery, comprised of rods, pedicle screw assemblies, and other components, intended for use as an adjunct to fusion. Its purpose is to physically support and stabilize the spine, not to diagnose medical conditions.
No
The device description explicitly lists physical components like rods, pedicle screw assemblies, and transverse-link assemblies, which are made from specific metal alloys. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that these are spinal systems comprised of implants (rods, screws, etc.) intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients. This is a surgical implant used within the body to treat specific spinal conditions.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Medyssey Co, Ltd. Zenius, Iliad and Kora Spinal Systems are 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, NKB
Device Description
The IliadTM Spinal Fixation and Adjustable Bridge 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 take into account the unique pathology of individual patients.
The KoraTM Spinal Fixation and Adjustable Bridge 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 take into account the unique pathology of individual patients.
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 take into account the unique pathology of individual patients.
For all three systems, components are manufactured from Ti6Al4V ELI per ASTM F136 and wrought Co-Cr-Mo alloy per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The additional components being added in this submission do not represent a new worst case. Therefore, no new performance testing is necessary to justify their substantial equivalence. Static and dynamic compression bending, static torsion and per ASTM F1717 was performed on the predicate worst constructs and presented in the predicate submissions.
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.
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
510(k) Summary
| Date Prepared: | June 20, 2013 |
|---|---|
| Contact: | John Kuczynski, VP R&D and RA |
| Medyssey USA Inc. | |
| 1550 E. Higgins Road | |
| Suite 123 | |
| Skokie, IL 60077 | |
| 847-427-0200 | |
| 888-518-9070 (fax) | |
| Trade Names: | Iliad Pedicle Screw System |
| Kora Pedicle Screw System | |
| Zenius Pedicle Screw System | |
| Product Class: | Class III |
| Classification: | 21 CFR §888.3070 Pedicle Screw Spinal System |
| Common Name: | Pedicle Screw System |
| Product Codes: | MNI, MNH, NKB |
| Panel Code: | 87 |
Purpose:
The purpose of this Premarket Notification is to add sizes of components to these three previously cleared pedicle screw systems and to change the indications for use for all systems to be consistent with the NKB (Class III) indications for pedicle screw systems.
Indications for Use:
The Medyssey Co, Ltd. Zenius, Iliad and Kora Spinal Systems are 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Descriptions:
The IliadTM Spinal Fixation and Adjustable Bridge 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 take into account the unique pathology of individual patients.
The KoraTM Spinal Fixation and Adjustable Bridge 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
1
are available so that adaptations can be utilized to take into account the unique pathology of individual patients.
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 take into account the unique pathology of individual patients.
For all three systems, components are manufactured from Ti6Al4V ELI per ASTM F136 and wrought Co-Cr-Mo alloy per ASTM F1537.
Predicate Device(s):
The Medyssey Pedicle Screw Systems are substantially equivalent to the Zenius, Iliad and Kora pedicle screw systems found in K121670, K110283 and K110284.
Performance Standards:
The additional components being added in this submission do not represent a new worst case. Therefore, no new performance testing is necessary to justify their substantial equivalence. Static and dynamic compression bending, static torsion and per ASTM F1717 was performed on the predicate worst constructs and presented in the predicate submissions.
Conclusion:
Medyssey concludes that these Pedicle Screw Systems are substantially equivalent to the predicate Pedicle Screw Systems with the same names and raise no new questions of safety or effectiveness.
a
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
Medyssey USA, Incorporated % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 13540 Guild Avenue Apple Valley. Minnesota 55124
Re: K131878
Trade/Device Name: Iliad, Kora and Zenius Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 25, 2013 Received: June 27, 2013
Dear Dr. Jansen:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Rich Jansen, Pharm.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
The Medyssey Co, Ltd. Zenius, Iliad and Kora Spinal Systems are 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 disiocation): spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131878