(216 days)
No
The device description and performance studies focus on mechanical components and testing, with no mention of AI, ML, or related concepts.
Yes
The device is a spinal fixation system, used as an adjunct to fusion for various spinal conditions, which are therapeutic interventions.
No
This device is a Spinal Fixation System, which is an implantable medical device used to stabilize the spine, not to diagnose a condition. Its function is to fix the spine as an adjunct to fusion for various indications like degenerative disc disease, spondylolisthesis, trauma, etc.
No
The device description explicitly lists physical components like screws, rods, and connectors, indicating it is a hardware-based medical device.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a Spinal Fixation System. This system is comprised of physical components (screws, rods, etc.) that are surgically implanted into the spine to provide stability and support as an adjunct to fusion.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens or providing diagnostic information based on such analysis. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWQ, KWP
Device Description
The Spinal Fixation System is available in various lengths. This system is comprised of screws, set screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.5 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper. The LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal fixation devices, posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5)
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)
The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System with the predicate device (K120270, K143363, K171813, K183168).
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.
K143363, K171813, K183168, K120270
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
October 28, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
L&K BIOMED Co., Ltd. KiHyang Kim Official Correspondent #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do 17015 Republic Of Korea
Re: K200790
Trade/Device Name: LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: September 28, 2020 Received: September 28, 2020
Dear KiHyang 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
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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200790
Device Name LnK Spinal Fixation System OpenLoc-L Spinal Fixation System
Indications for Use (Describe)
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
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)
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510(K) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. Manufacturer
| Submitter: | L&K BIOMED Co., Ltd. |
|---|---|
| #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, | |
| Yongin-si, Gyeonggi-do, 17015, Korea | |
| Phone. +82-10-5477-0325 | |
| Contact Person: | KiHyang Kim |
| e-mail: khkim@lnkbiomed.com |
2. Device Identification
| Trade Name | LnK Spinal Fixation System
OpenLoc-L Spinal Fixation System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Thoracolumbosacral pedicle screw system |
| Class | Class II |
| Product Code | NKB, KWP, KWQ |
| Common Name | Thoracolumbosacral pedicle screw system
Spinal interlaminal fixation orthosis
Spinal intervertebral body fixation orthosis |
| Regulation No. | 21 CFR 888.3070 |
| Panel | Orthopedic |
Predicate or legally marketed devices which are substantially equivalent 3.
The additional components of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have same design, materials, scientific technology, and indications for use.
Primary Predicate: LnK Spinal Fixation System (K143363)
Additional Predicates: LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System (K171813, K183168) LnK Spinal Fixation System (K120270)
Description of the Device 4.
The Spinal Fixation System is available in various lengths. This system is comprised of screws, set screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.5 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
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5. Materials
The LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This this is the same material used in the predicate devices.
6. Indication for Use
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
7. Performance Testing
The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System with the predicate device (K120270, K143363, K171813, K183168).
8. Summary of Technology Characteristics
LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are substantially equivalent to the predicate devices in terms of design, materials and indications for use.
9. Substantial Equivalence
LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System were shown to be substantially equivalent to the predicate devices in indications for use, design, function and materials used.
10. Conclusion
The additional components of LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System perform as well as the predicate devices. Therefore, the additional components are substantially equivalent to the predicate devices (K120270, K143363, K171813 and K183168).