PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

AI/ML Overview

The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.

This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Test Standard)	Specific Test Description	Reported Device Performance
ASTM F2077-18	Static Axial Compression	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
	Static Compression-Shear	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
	Static Torsion	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
	Dynamic Axial Compression	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
	Dynamic Compression-Shear	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
ASTM F2267-04 (Reapproved 2018)/F 2077-18	Static Subsidence	Met pre-defined criteria; showed higher or similar mechanical value than predicate.
Overall		"Met all pre-defined acceptance criteria and, in tests where it was compared to either PathLoc Lumbar Interbody Fusion Cage System the predicate or reference device, was found to not represent a new worst case."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.

4. Adjudication Method for the Test Set:

Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done:

Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.

7. The Type of Ground Truth Used:

Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.

Summary

FDA 510(k) Clearance Letter - PathLoc Lumbar Interbody Fusion Cage System

Page 1

July 8, 2025

L&K BIOMED Co., Ltd.
Mrs. Kihayng Kim
Vice Chairman
#101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil
Giheung-gu, Yongin-si, Gyeonggi 17015
South Korea

Re: K251741
Trade/Device Name: PathLoc Lumbar Interbody Fusion Cage System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: June 5, 2025
Received: June 6, 2025

Dear Mrs. 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251741 - Mrs. Kihayng Kim Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251741 - Mrs. Kihayng Kim Page 3

Sincerely,

Katherine D. Kavlock -S

for
Brent Showalter, Ph.D.
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

Page 4

INDICATIONS FOR USE STATEMENT

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

Submission Number (if known)
K251741

Device Name
PathLoc Lumbar Interbody Fusion Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ 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.

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"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."

Page 5

510(k) SUMMARY

The following 510(k) summary is submitted as required by 21 CFR 807.92:

1. Manufacturer

Submitter: Gook Jin Kang
L&K BIOMED Co., Ltd.
#101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea
Phone. 82-2-6717-1983/ FAX .82-2-6717-1949
Date Prepared July 7, 2025
Contact Person: Kihyang Kim
khkim@lnkbiomed.com

2. Device Identification

Trade Name: PathLoc Lumbar Interbody Fusion Cage System
Common Name: Intervertebral Body Fusion Device
Product Code: MAX
Classification: Class II
Classification Name: Intervertebral body fusion device
Regulation No. 21 CFR 888.3080
Classification Panel: Orthopedic

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

The PathLoc Lumbar Interbody Fusion Cage System has undergone a comprehensive battery of nonclinical testing, including chemical, physical. Testing has provided reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence. The PathLoc Lumbar Interbody Fusion Cage System met all pre-defined acceptance criteria and, in tests where it was compared to either PathLoc Lumbar Interbody Fusion Cage System the predicate or reference device, was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.

The design feature, materials, intended use, operational principles and indications for use for the subject device 'PathLoc Lumbar Interbody Fusion Cage System' is substantially equivalent to the following predicate(s);

Primary Predicate Device: PathLoc Lumbar Interbody Fusion Cage System (K 213441)

The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use, intended use and operational principles.

4. Materials

PathLoc Lumbar Interbody Fusion Cage System is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). This is the same material used in the predicate devices.

K251741
Page 1 of 3

Page 6

5. Description of the Device

PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

6. Intended use

PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion System is to be used with supplemental fixation systems. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

7. Performance –Bench testing

The PathLoc Lumbar Interbody Fusion Cage System was tested according to the ASTM F 2077, ASTM F 2267

Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the PathLoc Lumbar Interbody Fusion Cage System to the predicate devices.

Static Axial Compression Test – ASTM F 2077 -18
Static Compression-Shear Test - ASTM F 2077 -18
Static Torsion Test - ASTM F 2077 -18
Static Subsidence Test – ASTM F 2267 – 04 (Reapproved 2018)/F 2077-18
Dynamic Axial Compression Test– ASTM F 2077 -18
Dynamic Compression-Shear Test - ASTM F 2077 -18

Bench testing to evaluate the mechanical properties of the PathLoc Lumbar Interbody Fusion Cage System showed a higher or similar mechanical value than predicate marketed devices.

8. Summary of Technology Characteristics

PathLoc Lumbar Interbody Fusion Cage System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use and sizing.

9. Biocompatibility

The device is made of Titanium 6AL-4V Alloy conforming to ASTM F136 which is widely known to be biocompatible.

K251741
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Page 7

10. Substantial Equivalence:

PathLoc Lumbar Interbody Fusion Cage System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

11. Conclusion

The information presented demonstrates the substantial equivalency of the PathLoc Lumbar Interbody Fusion Cage System to the predicate devices.

K251741
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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.