(304 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
No.
The device is described as a "Spinal Fixation System" intended to stabilize and promote spinal fusion as an adjunct to fusion, rather than directly treating or mitigating a disease or condition.
No
This device is a spinal fixation system, intended to stabilize and promote spinal fusion as an adjunct to fusion, not to diagnose a condition.
No
The device description explicitly states it consists of physical components like pedicle screws, set screws, rod connectors, and a crosslink linking mechanism, fabricated from titanium alloy and cobalt-chromium-molybdenum. This indicates it is a hardware-based medical device, not software-only.
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 system for spinal fixation. It is used in the body to stabilize the spine.
- Device Description: The description details physical components like screws, rods, and connectors made of metal alloys. These are physical implants, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The Advanced LumFix Spinal Fixation 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 Advanced Lumfix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rod connectors and a crosslink linking mechanism.
The Advanced Lumfix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Advanced Lumfix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle
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)
Mechanical testing that was conducted in accordance with ASTM F1798 demonstrates equivalence to the above predicate devices.
Mechanical test reports were completed for the following test methods:
- . Static test: Compression and Torsion test report (ASTM F1717-11, 18, 21)
- Dynamic test: Compression Fatigue test report (ASTM F1717-11, 18) ●
- Static Axial Grip, Static Torsional Grip, and Static and Dynamic Transverse Moment (ASTM F1798-13)
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
May 25, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font size than the rest of the text.
CG Bio Co., Ltd. Iris Kim Official Correspondent B1, 1F, 2F, C-dong, 29, Jeyakdanji-ro, Hyangnam-eup Hwaseong-Si, Gyeonggi-Do 18608 Korea, South
Re: K222229
Trade/Device Name: Advanced LumFix Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: April 28, 2023 Received: April 28, 2023
Dear Iris 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 (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,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. To the right of the text is a faded, stylized logo that appears to be the letters "FDA".
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) K22229
Device Name Advanced LumFix Spinal Fixation System
Indications for Use (Describe)
The Advanced LumFix Spinal Fixation 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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for CGBIO, a cell and growth factor biotechnology company. The logo features the letters "CGBIO" in large, bold, orange font. Below the letters, in a smaller font, are the words "CELL & GROWTH FACTOR BIOTECHNOLOGY".
3rd Floor, Hannam Bd.211, Itaewon-Ro,
3. 510(k) Summary or 510(k) Statement
510(k) Summary
| 1. | Manufacturer | CG Bio Co., Ltd. |
|---|---|---|
| B1, 1F, 2F, C-dong, 29, Jeyakdanji-ro, Hyangnam-eup | ||
| Hwaseong-Si, Gyeonggi-Do, Republic of Korea | ||
| +82-2-550-8300 | ||
| 2. | Company Contact | Iris Kim(iriskim@cgbio.co.kr) |
| 3. | Official Correspondent | Iris Kim |
| 4. | Proprietary Trade Name | Advanced LumFix Spinal Fixation System |
| 5. | Common Name | Pedicle Screw Spinal Fixation System |
| 6. | Classification Name | 888.3070 – Thoracolumbosacral Pedicle Screw System |
| Classification | Class II | |
| Product Codes | NKB | |
| 7. | Date Prepared | 7/20/2022 |
General Description
The Advanced Lumfix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rod connectors and a crosslink linking mechanism.
The Advanced Lumfix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Advanced Lumfix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.
4
Image /page/4/Picture/0 description: The image shows the logo for CGBIO, a cell and growth factor biotechnology company. The letters "CGBIO" are displayed in large, bold, orange font. Below the letters, in a smaller font, the words "CELL & GROWTH FACTOR BIOTECHNOLOGY" are written in blue.
K222229 Page 2 of 2
Indications for Use
The Advanced LumFix Spinal Fixation System is intended for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft 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.
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- Primary Predicate - K160731: Lumfix Spinal Fixation System, CG Bio Co., Ltd.
- Additional Predicate K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System, Medyssey ● USA
- Additional Predicate - K190471: 4CIS Chiron Spinal Fixation System, Solco Biomedical, Co., Ltd.
Summary of the Technological Characteristics with the Predicate Devices
The Advanced Lumfix Spinal Fixation System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. There are slight differences between the length and diameter of screws and rod diameter. But the subject device -Advanced Lumfix Spinal Fixation System -has similar technological characteristics including design, intended use, material composition, function and fundamental technologies as predicate devices.
Non-clinical testing
Mechanical testing that was conducted in accordance with ASTM F1798 demonstrates equivalence to the above predicate devices.
Mechanical test reports were completed for the following test methods:
- . Static test: Compression and Torsion test report (ASTM F1717-11, 18, 21)
- Dynamic test: Compression Fatigue test report (ASTM F1717-11, 18) ●
- Static Axial Grip, Static Torsional Grip, and Static and Dynamic Transverse Moment (ASTM F1798-13)
Conclusion
Testing and other comparisons have established that the Advanced Lumfix Spinal Fixation System is substantially equivalent in design, materials, indications, and performance to other predicate devices.