(43 days)
No
The description focuses on the mechanical components and materials of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is intended to treat acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, indicating a therapeutic purpose.
No
This device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists hardware components (Pedicle Screw, Set Screw, Rod, Cross Link) made of a titanium alloy. This indicates it is a physical implant system, not a software-only device.
Based on the provided information, the Xpine Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
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 for diagnosis, monitoring, or screening.
- Xpine Spinal Fixation System Function: The description clearly states that the Xpine Spinal Fixation System is an implantable device used for surgical fixation and stabilization of the spine. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use describes treating spinal instabilities and deformities through surgical intervention, not through the analysis of biological samples.
Therefore, the Xpine Spinal Fixation System falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Xpine Spinal Fixation System is 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:
- · 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
- · failed previous fusion
Product codes
NKB
Device Description
The Xpine Spinal Fixation System, Internal Fixation Device for Spinal Surgery, is comprised of: Pedicle Screw, Set Screw. Rod. and Cross Link. Various forms and sizes of these implants are available to consider the unique pathology of individual patients for purposes of stabilization, or corrective action through the application of force. Components are made of Ti6Al4V ELI, a titanium-based alloy, which complies with ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral 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
Bench tests were conducted to demonstrate substantial equivalence to the predicate device. The tests were conducted according to the following standards:
- · ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static and dynamic axial compression bending testing
- Static torsion testing
Clinical data is not applicable.
Bench tests were conducted for the subject device according to ASTM F1717. All test results were higher than the acceptance criteria from the reference literature. Substantially equivalent mechanical performance with the predicate device has been demonstrated.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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November 8, 2024
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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Jeil Medical Corporation Jinwoo Kim Kim RA Specialist 702•703•704•705•706•804•805•807•812•815-ho, 55 Digital-ro 34-gil, Guro-gu Seoul. 08378 Korea, South
Re: K243004
Trade/Device Name: Xpine Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 26, 2024 Received: September 26, 2024
Dear Jinwoo Kim Kim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Image /page/2/Figure/2 description: The image shows a digital signature. The signature is from RYAN TROMBETTA -S, and the date of the signature is 2024.11.08 14:11:02 -05'00'. The signature is for Colin O'Neill, M.B.E., Assistant Director.
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
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Indications for Use
Submission Number (if known)
Device Name
Xpine Spinal Fixation System
Indications for Use (Describe)
Xpine Spinal Fixation System is 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:
- · 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
- · 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)
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K243004 Page 1 of 1
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Image /page/4/Picture/0 description: The image shows the logo for JEILMEDICAL, followed by the address: 702,703,704,705,706,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Korea. The phone number is +82 2 850 3500 and the fax number is +82 2 850 3535.
510(k) Summary
K243004 Prepared on November 5, 2024
1. Contact Details [21 CFR 807.92(a)(1)]
| • Applicant Name: | Jeil Medical Corporation |
|---|---|
| • Applicant Address: | 702-703-704-705-706-804-805-807-812-815-ho, |
| 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Republic of Korea | |
| • Applicant Contact Telephone: | +82 2 850 3934 |
| • Applicant Contact: | Ms. Jinwoo Kim |
| • Applicant Contact Email: | jinwookim@jeilmed.co.kr |
2. Device Name [21 CFR 807.92(a)(2)]
| • Device Trade Name: | Xpine Spinal Fixation System |
|---|---|
| • Common Name: | Thoracolumbosacral pedicle screw system |
| • Classification Name: | Thoracolumbosacral Pedicle Screw System |
| • Regulation Number: | 888.3070 |
| • Product Code(s): | NKB |
3. Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K142381 | Xia® 3 Spinal System | NKB |
| K231887 | ARIX Ankle Distal Tibia System (Reference Device) | HRS |
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4. Device Description Summary [21 CFR 807.92(a)(4)]
The Xpine Spinal Fixation System, Internal Fixation Device for Spinal Surgery, is comprised of: Pedicle Screw, Set Screw. Rod. and Cross Link. Various forms and sizes of these implants are available to consider the unique pathology of individual patients for purposes of stabilization, or corrective action through the application of force. Components are made of Ti6Al4V ELI, a titanium-based alloy, which complies with ASTM F136.
5. Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
Xpine Spinal Fixation System is intended to provide immobilization 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:
· 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
- · failed previous fusion
6. Indications for Use Comparison [21 CFR 807.92(a)(5)]
The difference in indications for use between the subject and the predicate device (Xia® 3 Spinal System) is that the subject device is only intended to be used as a non-cervical pedicle screw system in adult patients, while the predicate device is not only used as that but intended to be used as an anterior/anterolateral, non-pedicle screw, and in pediatric patients also. This difference does not constitute a new intended use.
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7. Technological Comparison [21 CFR 807.92(a)(6)]
Based on the technological feature comparison, the subject device was found to have no significant differences between the subject device and predicate devices that would adversely affect the use of the product, and it is substantially equivalent to the predicate device in technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The subject device and predicate device are the Thoracolumbosacral Pedicle Screw System. Both are made of Titanium Alloy (ASTM F136), and provided non-sterile. Detailed design/dimension would not be the same, but equivalent.
Bench tests were conducted to demonstrate substantial equivalence to the predicate device. The tests were conducted according to the following standards:
- · ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static and dynamic axial compression bending testing
- Static torsion testing
Clinical data is not applicable.
Bench tests were conducted for the subject device according to ASTM F1717. All test results were higher than the acceptance criteria from the reference literature. Substantially equivalent mechanical performance with the predicate device has been demonstrated.
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence for its intended use.