CastleLoc-S Posterior Cervical Fixation System

K231840 · L&K BIOMED Co., Ltd. · NKG · Jul 20, 2023 · Orthopedic

Device Facts

• Record ID: K231840
• Device Name: CastleLoc-S Posterior Cervical Fixation System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: NKG · Orthopedic
• Decision Date: Jul 20, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Top-loading posterior cervical-thoracic spinal fixation system; components include poly screws, reduction screws, rods, set screws, hooks, and accessories. Used in open surgical procedures by surgeons to immobilize and stabilize spinal segments. System provides structural support as adjunct to fusion or for temporary stabilization in palliative tumor cases. Can be linked to other L&K Biomed fixation systems (LnK, OpenLoc-L, AccelFix) via connectors. Provides mechanical stabilization to alleviate pain and restore spinal integrity.

Clinical Evidence

No clinical data. Bench testing only; reliance on mechanical test data from predicate devices (K103414, K120879, K143278, K162136, K200793) and risk assessment for additional components.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). Components: poly screws, reduction screws, rods, set screws, hooks. Mechanical testing per ASTM F1717 (static compression bending and static torsion).

Indications for Use

Indicated for patients with acute/chronic cervical (C1-C7) and thoracic (T1-T3) spine instabilities, including traumatic fractures/dislocations, deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column stabilization in patients with advanced cervical tumors and limited life expectancy where fusion is not achievable.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LnK Posterior Cervical Fixation System (K143278)
• LnK Posterior Cervical Fixation System (K120879)
• LnK Posterior Cervical Fixation System (K103414)
• LnK Posterior Cervical Fixation System and CastleLoc-S (K162136)
• Posterior Cervical Fixation System (K200793)
• MegaCerfix Posterior Cervical Fixation System (K210035)
• Paeon Posterior Cervical Fixation System (K221050)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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) | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black;"><span style="position:relative; top:-2px; left:1px;"><b>X</b></span></div> |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black;"></div> |

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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's Name: | L&K Biomed Co., Ltd. |
|------------------------|-----------------------------------------------------------------------------------------------------------|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil<br>Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea. |
| Submitter's Telephone: | 82-2-6717-1983 |
| Contact Person: | Katherine Kim/82-2-6717-1983<br>[e-mail] |
| 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<br>Fixation System | Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-<br>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<br>CastleLoc-S Posterior<br>Cervical Fixation System | | Similar | Same | Identical<br>device | Same |
| LnK Posterior Cervical<br>Fixation System and<br>CastleLoc-S Posterior<br>Cervical Fixation System | K103414<br>K120879<br>K143278<br>K162136<br>K200793 | Similar | Same | Identical<br>device | Same |
| Paeon Posterior Cervical<br>Fixation System | K 210035<br>K 221050 | Similar | Same | Identical<br>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).