(196 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities, deformities, and degenerative diseases of the cervical spine. It aims to alleviate symptoms like intractable radiculopathy, neck and/or arm pain, which are therapeutic goals.
No
The device description indicates it is a "multi-component, posterior (cervical-thoracic) spinal fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion". This describes a surgical implant, not a device used for diagnosis.
No
The device description explicitly lists multiple hardware components (screws, rods, hooks, etc.) used in a surgical procedure.
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 designed to provide immobilization and stabilization of spinal segments. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device description details components like screws, rods, and hooks, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.
Product codes
NKG, KWP
Device Description
The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semireduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7) and the thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
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
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 Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System with the predicate device (K103414, K120879, K143278 and K162136).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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October 8, 2020
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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font. The FDA logo is a recognizable symbol of the agency's mission to protect and promote public health.
L&K BIOMED Co., Ltd. Minju Choi Official Correspondent #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do 17015 Korea
Re: K200793
Trade/Device Name: LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: September 21, 2020 Received: September 21, 2020
Dear Ms. Choi:
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) K200793
Device Name
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
Indications for Use (Describe)
The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.
| 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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Image /page/3/Picture/1 description: The image shows the logo for L&K BIOMED. The logo is in dark blue and features the text "L&K BIOMED" in a bold, sans-serif font. Above the text, there is the text "LEARNING & KNOWLEDGE BIOMED" in a smaller font. To the right of the text, there is a circular graphic made up of several smaller circles in varying shades of blue.
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: | Minju Choi |
| e-mail: jung9844@lnkbiomed.com | |
| Date prepared: | March 25, 2020 |
2. Device Identification
| Trade Name | LnK Posterior Cervical Fixation System,
CastleLoc-S Posterior Cervical Fixation System |
|---------------------|-------------------------------------------------------------------------------------------|
| Common Name | Spinal Fixation System |
| Product Code | NKG, KWP |
| Regulatory Class | Class II (21 CFR 888.3075); Class II (21 CFR 888.3050) |
| Classification Name | Posterior Cervical Screw System
Spinal interlaminal fixation orthosis |
3. Predicate or legally marketed devices which are substantially equivalent.
The additional models of the LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical 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 Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K162136)
-Additional predicate device:
LnK Posterior Cervical Fixation System (K103414, K120879, K143278)
4. Description of the Device
The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semireduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.
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5. Materials
The LnK Posterior Cervical Fixation and CastleLoc-S Posterior Cervical Fixation System are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This is the same material
used in the predicate devices.
6. Indication for Use
The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.
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 Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System with the predicate device (K103414, K120879, K143278 and K162136).
Summary of Technology Characteristics 8.
LnK Posterior Cervical Fixation and CastleLoc-S Posterior Cervical Fixation System are substantially equivalent to the predicate devices in terms of design, materials, same manufacturing process and indications for use.
Substantial Equivalence 9.
LnK Posterior Cervical Fixation and CastleLoc-S Posterior Cervical Fixation System were shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process function and materials used.
10. Conclusion
The information presented demonstrates the substantial equivalency of the additional components of LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System to the predicate devices (K103414, K120879, K143278 and K162136).