(723 days)
Not Found
No
The 510(k) summary describes a traditional mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
No
The device is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion, which falls under surgical hardware rather than a therapeutic device in the context of actively treating a condition without surgical implantation.
No
Explanation: The EDEN Spinal Fixation System is a pedicle screw and rod system designed for immobilization and stabilization of the spine as an adjunct to fusion. It is a surgical implant device, not a device used to diagnose medical conditions.
No
The device description explicitly states it consists of pedicle screws, rods, cross links, set screws, and instruments, which are all hardware components.
Based on the provided information, the EDEN Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like pedicle screws, rods, cross links, and instruments used in surgery. These are all physical devices for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The EDEN Spinal Fixation System is a surgical implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.
Product codes
NKB
Device Description
The EDEN Spinal Fixation System is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion. The EDEN Spinal Fixation System consists of pedicle screws, rods, cross links, and set screws that can be used via percutaneous surgical approach. The components are available in a variety of designs and sizes in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.
The EDEN Spinal Fixation System also offer a wide variety of instrument that range from bone awls to screwdrivers.
They are made of various grades of stainless steel and aluminum alloys. All the items are supplied non-sterile and must be sterilized prior to use. We believe orthopedic instrument is Class I, 510k exempt. The information here is provided for informational purpose only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non- cervical spine
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
Non-Clinical Testing:
- Sterilization validation testing per ISO 17665-1 and 17665-2
- Biocompatibility testing per ISO 10993
- Static flexion/extension testing per ASTM F1798
- Foam block pullout testing per ASTM F543
- Static and dynamic compression bending, static torsion, and static tension testing per ASTM F1717
Key results: the results support that the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 23, 2022
Image /page/0/Picture/1 description: The image shows 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
JMT Co., Ltd % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K201788
Trade/Device Name: EDEN Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 14, 2022 Received: June 16, 2022
Dear Priscilla Chung:
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,
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) K201788
Device Name EDEN Spinal Fixation System
Indications for Use (Describe)
The EDEN Spinal Fixation System is intended to provide immobilization and stabilization
of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
510(k) Summary
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 6/22/2022
1. Submitter
JMT Co., Ltd (11517) 70-39, Gwonyul-ro 1203 beon-gile, Baekseok-eup, Yangju-si Gyeonggi-do, Republic of Korea Tel. +82-31-868-0951
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Trade Name: EDEN Spinal Fixation System
- Common Name: Non-Sterile Spinal Fixation System ●
- Classification Name: Thoracolumbosacral pedicle screw system ●
- Product Code: NKB ●
- Classification regulation: 21CFR 888.3070 ●
4. Predicate Device:
GALAXY MIS Screw System by BM KOREA Co., Ltd. (K143110)
5. Description:
The EDEN Spinal Fixation System is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion. The EDEN Spinal Fixation System consists of pedicle screws, rods, cross links, and set screws that can be used via percutaneous surgical approach. The components are available in a variety of designs and sizes in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.
4
The EDEN Spinal Fixation System also offer a wide variety of instrument that range from bone awls to screwdrivers.
They are made of various grades of stainless steel and aluminum alloys. All the items are supplied non-sterile and must be sterilized prior to use. We believe orthopedic instrument is Class I, 510k exempt. The information here is provided for informational purpose only.
6. Indication for use:
The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.
7. Basis for Substantial Equivalence
The subject device is substantially equivalent to GALAXY MIS Screw System (K143110) by BM KOREA Co., Ltd.
Substantial Equivalence Discussion
The subject device is substantially equivalent to the GALAXY MIS Screw System by BM KOREA Co., Ltd. (K143110).
The devices have the same indications for use and use the same materials. The designs are similar. We have conducted the performance tests and the results support that the subject device is substantially equivalent to the predicate device.
8. Non-Clinical Testing
- Sterilization validation testing per ISO 17665-1 and 17665-2 ●
- Biocompatibility testing per ISO 10993 ●
- Static flexion/extension testing per ASTM F1798
- Foam block pullout testing per ASTM F543 ●
- Static and dynamic compression bending, static torsion, and static tension testing per ASTM F1717
5
9. Conclusion
The subject device and the predicate device have the same intended use and have similar technological characteristics. Based on the similarities and the test results, we conclude that the EDEN Spinal Fixation System is substantially equivalent to the predicate device.