PathLoc Lumbar Interbody Fusion Cage System

K251741 · L&K BIOMED Co., Ltd. · MAX · Jul 8, 2025 · Orthopedic

Device Facts

• Record ID: K251741
• Device Name: PathLoc Lumbar Interbody Fusion Cage System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 8, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Hollow, rectangular interbody fusion cage; manufactured from Ti-6Al-4V ELI titanium alloy; features superior/inferior surface serrations for fixation. Implanted via transforaminal or posterior approach; expandable in height post-insertion using system instrumentation. Used by surgeons in clinical settings to aid spinal fusion in DDD patients. Provides structural support to intervertebral space; promotes fusion when used with bone graft and supplemental fixation. Benefits patients by stabilizing spinal segments and alleviating discogenic pain.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression, shear, and torsion testing per ASTM F2077 and ASTM F2267. Results demonstrate mechanical properties are similar or superior to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium alloy (ASTM F136). Form factor: Hollow, rectangular, expandable cage with serrated surfaces. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Algorithm: None.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis. Requires use with bone graft and supplemental fixation. Patients must have failed 6 months of non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PathLoc Lumbar Interbody Fusion Cage System (K213441)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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
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(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 ([e-mail]) or phone [phone] or 301-796-7100).

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K251741 - Mrs. Kihayng Kim
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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

# Indications for Use

Submission Number (if known)
K251741

Device Name
PathLoc Lumbar Interbody Fusion Cage System

Indications for Use (Describe)

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.

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)

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K251741
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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. [phone]/ FAX .[phone] |
| Date Prepared | July 7, 2025 |
| Contact Person: | Kihyang Kim
[e-mail] |

2. Device Identification

| Trade Name: | PathLoc Lumbar Interbody Fusion Cage System |
| --- | --- |
| Common Name: | Intervertebral Body Fusion Device |
| Product Code: | MAX |
| Classification: | ClassII |
| Classification Name: | Intervertebral body fusion device |
| Regulation No. | 21 CFR 888.3080 |
| Classification Pane | Orthopedic |

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

The PathLoc Lumbar Interbody Fusion Cage System has undergone a comprehensive battery of non-clinical 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);

1) 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.

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# 5. Description of the Device

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.

# 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.

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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.