(28 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing and equivalence to predicate devices, not algorithmic performance.
Yes
The device is intended to provide immobilization and stabilization of spinal segments for various acute and chronic instabilities, deformities, and degenerative diseases of the cervical and thoracic spine, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The provided text describes a "Posterior Cervical Fixation System" intended to provide stabilization and immobilization of spinal segments as an adjunct to fusion for various conditions. This description indicates it is a therapeutic or surgical device, not a device used for diagnosis.
No
The device description explicitly states it is a "multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, set screw, hooks and accessories". These are physical hardware components, not software.
Based on the provided information, the CastleLoc-S Posterior Cervical Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a system of screws, rods, set screws, hooks, and accessories made from titanium and cobalt chromium. These are materials and components typical of surgical implants, not diagnostic reagents or instruments used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the CastleLoc-S Posterior Cervical Fixation System falls under the category of a surgical implant or medical device used for structural support and stabilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fosion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); 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 CastleLoc-S Posterior Cervical Fixation System is 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. The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The CastleLoc-S Posterior Cervical Fixation System is a top-loading, multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The CastleLoc-S Posterior Cervical Fixation System is identical to the predicates; mechanical testing is not required to establish substantial equivalence.
A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The additional components to be added through this submission do not require additional mechanical testing. None of the additional sizes is the worst case of the CastleLoc-S Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of CastleLoc-S Posterior Cervical Fixation System with the predicate device (K103414, K120879, K143278, K162136, K200793).
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.
K143278, K120879, K103414, K162136, K200793
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.
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
§ 888.3075 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.
0
July 20, 2023
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. Katherine Kim RA #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil. Giheung-gu Yongin-si, Gyeonggi-do 17015 South Korea
Re: K231840
Trade/Device Name: 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: June 20, 2023 Received: June 22, 2023
Dear Katherine 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 -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231840
Device Name
CastleLoc-S Posterior Cervical Fixation System
Indications for Use (Describe)
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fosion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); 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 CastleLoc-S Posterior Cervical Fixation System is 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. The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. Manufacturer
| Submitter's Name: | L&K Biomed Co., Ltd. |
|---|---|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea. | |
| Submitter's Telephone: | 82-2-6717-1983 |
| Contact Person: | Katherine Kim/82-2-6717-1983 |
| khkim@lnkbiomed.com | |
| Prepared Date: | June 20, 2023 |
Device Identification 2.
| Device Trade Name | CastleLoc-S Posterior Cervical Fixation System |
|---|---|
| Common/Usual Name | Spinal Fixation System |
| Regulation Class /Number | Class II / 21 CFR 888.3075 / 21 CFR 888.3050 |
| Regulation Name | Posterior cervical screw system |
| Product Code | NKG, KWP |
| Classification Panel | Spinal Devices (DHT6B) |
Predicate or legally marketed devices which are substantially equivalent. 3.
The subject devices are identical to the predicate devices in all characteristics.
| 510k Number | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|
| K 143278 | LnK Posterior Cervical Fixation System | Primary |
| K 120879 | LnK Posterior Cervical Fixation System | |
| K 103414 | LnK Posterior Cervical Fixation System | Additional |
| K 162136 | LnK Posterior Cervical Fixation System and CastleLoc-S | |
| K 200793 | Posterior Cervical Fixation System | |
| K 210035 | MegaCerfix(Former name) Posterior Cervical Fixation System | Additional |
| K 221050 | Paeon Posterior Cervical Fixation System |
The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
Materials 4.
| CastleLoc-S Posterior Cervical
Fixation System | Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-
28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537) |
| --------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- |
|---|
5. Description of the Device
The CastleLoc-S Posterior Cervical Fixation System is a top-loading, multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.
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Image /page/4/Picture/0 description: The image shows the logo for L&K Biomed, along with the text "K231840 Page 2 of 2". The logo consists of the text "L&K Biomed" in a sans-serif font, with a circular graphic to the left of the text. The text "K231840" and "Page 2 of 2" are located to the right of the logo.
6. INDICATION FOR USE
The CastleLoc-S Posterior Cervical Fixation System is 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., pseudoarthrosis); 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 CastleLoc-S Posterior Cervical Fixation System is 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. The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod connector and transitional rod.
7. Performance Testing
The CastleLoc-S Posterior Cervical Fixation System is identical to the predicates; mechanical testing is not required to establish substantial equivalence.
A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The additional components to be added through this submission do not require additional mechanical testing. None of the additional sizes is the worst case of the CastleLoc-S Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of CastleLoc-S Posterior Cervical Fixation System with the predicate device (K103414, K120879, K143278, K162136, K200793).
Summary of Technology Characteristics 8.
Subject devices are identical to the predicate devices, material, design, mechanism, indication for use and manufacturing process in all characteristics.
Substantial Equivalence 9.
Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process, function and materials used.
| 510K no. | Indication for use | Material | Design | Sterilization Method | |
|---|---|---|---|---|---|
| Subject CastleLoc-S | |||||
| CastleLoc-S Posterior | |||||
| Cervical Fixation System | Similar | Same | Identical | ||
| device | Same | ||||
| LnK Posterior Cervical | |||||
| Fixation System and | |||||
| CastleLoc-S Posterior | |||||
| Cervical Fixation System | K103414 | ||||
| K120879 | |||||
| K143278 | |||||
| K162136 | |||||
| K200793 | Similar | Same | Identical | ||
| device | Same | ||||
| Paeon Posterior Cervical | |||||
| Fixation System | K 210035 | ||||
| K 221050 | Similar | Same | Identical | ||
| device | Same |
10. Conclusion
The overall technology characteristics lead to the conclusion that the CastleLoc-S Posterior Cervical Fixation System is substantially equivalent to the predicate devices (K103414, K120879, K143278, K162136, K200793).