LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System

K200789 · L&K BIOMED Co., Ltd. · NKB · Dec 4, 2020 · Orthopedic

Device Facts

• Record ID: K200789
• Device Name: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Dec 4, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MIS Spinal System can be used in an open approach and a percutaneous approach. The MIS Spinal System is intended for the following indications: Degenerative disc disease (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, lordosis), Tumor, Pseudarthrosis, Failed previous fusion

Device Story

System comprises cannulated polyaxial screws, straight/curved rods, and set screws; used for spinal immobilization/stabilization. Designed for open or percutaneous surgical approaches. Components available in various diameters/lengths to match patient anatomy. Used by surgeons in clinical/OR settings to treat spinal instabilities or deformities. Provides mechanical stabilization to facilitate fusion; benefits patients by addressing chronic/acute spinal conditions.

Clinical Evidence

No clinical data. Bench testing only; mechanical performance of additional components was established by comparison to previously cleared predicate devices.

Technological Characteristics

Materials: Titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537). Components: Cannulated polyaxial screws, straight/curved rods, set screws. Form factor: Various diameters and lengths. Mechanical fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal segment immobilization as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AccelFix-MIS Spinal System (K182544)
• LnK MIS Spinal System (K112643, K120140, K161766, K183117)
• PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117)

Submission Summary (Full Text)

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December 4, 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 and 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. Minju Choi Official Correspondent #201, #202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 Republic of Korea

Re: K200789

Trade/Device Name: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: November 6, 2020 Received: November 9, 2020

Dear Minju 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

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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 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 ([e-mail]) or phone [phone] 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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# Indications for Use

510(k) Number (if known) K200789

Device Name LnK MIS Spinal System PathLoc-L MIS Spinal System

#### Indications for Use (Describe)

The MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MIS Spinal System can be used in an open approach and a percutaneous approach.

The MIS Spinal System is intended for the following indications:

Degenerative disc disease (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, lordosis), Tumor, Pseudarthrosis, Failed previous fusion

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

T

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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# Indications for Use

510(k) Number (if known) K200789

Device Name AccelFix-MIS Spinal System

Indications for Use (Describe)

The MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MIS Spinal System can be used in an open approach and a percutaneous approach.

The MIS Spinal System is intended for the following indications:

Degenerative disc disease (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, lordosis), Tumor, Pseudarthrosis, Failed previous fusion

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: [phone] |
| Contact Person: | Min Ju Choi |
| | e-mail: [e-mail] |

## 2. Device Identification

| Trade Name | LnK MIS Spinal System<br>PathLoc-L MIS Spinal System<br>AccelFix-MIS Spinal System |
|---------------------|------------------------------------------------------------------------------------|
| Common Name | Pedicle Screw Spinal System |
| Class | Class II |
| Product Code | NKB |
| Classification Name | Thoracolumbosacral pedicle screw system |
| Regulation No. | (21 CFR 888.3070) |
| Panel | Orthopedic |

## 3. Predicate or legally marketed devices which are substantially equivalent.

The additional models of the LnK MIS Spinal System, PathLoc-L MIS Spinal System and AccelFix-MIS Spinal System are considered substantially equivalent to the predicate devices. The systems have same design, scientific technology, and indications for use.

Primary Predicate: AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117)

#### 4. Description of the Device

The MIS spinal system consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537).

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#### 5. Indication for Use

The MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MIS Spinal System can be used in an open approach and a percutaneous approach. The MIS Spinal System is intended for the following indications: Degenerative disc disease (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, lordosis), Tumor, Pseudarthrosis, Failed previous fusion.

## 6. 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 MIS Spinal System, PathLoc-L MIS Spinal System and AccelFix-MIS Spinal System. Therefore, we substitute mechanical test data of additional components of LnK MIS Spinal System, PathLoc-L MIS Spinal System and AccelFix-MIS Spinal System with the predicate device (K112643, K120140, K161766, K183117, K 182544).

## 7. Summary of Technology Characteristics

LnK MIS Spinal System, PathLoc-L MIS Spinal System and AccelFix-MIS Spinal System are substantially equivalent to the predicate devices in terms of design, scientific technology, same manufacturing process and indications for use.

## 8. Substantial Equivalence

LnK MIS Spinal System, PathLoc-L MIS Spinal System and AccelFix-MIS Spinal Fixation System were shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process and function.

## 9. Conclusion

The additional components perform as well as the predicate device. Therefore, the additional components of AccelFix MIS Spinal System, LnK MIS Spinal System and PathLoc-L MIS Spinal System are substantially equivalent to the predicate device (K112643, K120140, K161766, K183117, K182544).