PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Device Description

The PathLoc-TA Expandable Lumbar Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies.

The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on comparison to predicate devices and established ASTM standards. The reported performance is generally qualitative, stating the device performance is "higher or similar" to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical properties meet or exceed predicate devices.	Bench testing showed "higher or similar mechanical value" than predicate devices.
Compliance with ASTM F2077 for static and dynamic compression.	Testing was "presented to demonstrate the substantial equivalency".
Compliance with ASTM F2077 for static and dynamic shear.	Testing was "presented to demonstrate the substantial equivalency".
Compliance with ASTM draft F-04.25.02.02 for static expulsion.	Testing was "presented to demonstrate the substantial equivalency".
Compliance with ASTM F2267 for static subsidence.	Testing was "presented to demonstrate the substantial equivalency".
Identical technological characteristics to predicate devices.	"The subject and predicate devices have identical technological characteristics".
No new issues of safety and effectiveness compared to predicates.	"there is not any new issues of safety and effectiveness".

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide details about the sample size for the mechanical tests, nor does it specify the provenance of the data (country of origin, retrospective/prospective). It only mentions "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The study described is a benchtop mechanical testing study, not a clinical study involving experts establishing ground truth from patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable, as it was a benchtop mechanical testing study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was done. The document describes a 510(k) submission for a physical medical device (intervertebral cage), not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is derived from established ASTM standards for mechanical testing of intervertebral body fusion devices, and the comparative performance of legally marketed predicate devices. The "truth" is whether the device's mechanical properties meet the standards and are equivalent or superior to existing devices.

8. The sample size for the training set

This information is not applicable, as this is a mechanical testing study for a physical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable, as this is a mechanical testing study for a physical device, not a machine learning model.

Summary

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January 13, 2023

L&K Biomed Co., Ltd. Katherine Kim RA 101, 201, 202 16-25, Dongbaekjungang-ro16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea

Re: K223474

Trade/Device Name: PathLoc-TA Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 15, 2022 Received: November 18, 2022

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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 Ouality 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) K223474

Device Name

PathLoc-TA Expandable Lumbar Cage System

Indications for Use (Describe)

Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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

1. SUBMITTER

Submitter's Name:	L&K BIOMED Co., Ltd.
Submitter's Address:	#201, 202 16-25, Dongbaekjungang-ro 16 beon-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea
Submitter's Telephone:	+82-2-6717-1983
Contact Person:	Katherine Kimkhkim@lnkbiomed.com / ra@lnkbiomed.com

2. DEVICE NAME

Trade or Proprietary Name	PathLoc-TA Expandable Lumbar Cage System
Common or Usual Name	Intervertebral Body Fusion Device, Intervertebral cage, Spacer
Regulation class / Number	ClassII, CFR 888.3080
Regulation Name	Intervertebral Body Fusion Device
Product Code	MAX
Classification Panel	Spinal Devices (DHT6B)

3. PREDICATE DEVICE

The subject PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to the following devices:

Primary Predicate Device: ABTross ALIF Expandable Lumbar Cage System(K221719)

4. DESCRIPTION OF THE DEVICE

INDICATION FOR USE న్.

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(DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

6. PERFORMANCE DATA

Performance testing was performed to demonstrate that the subject PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to other predicate devices.

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

Static Axial Compression Test ASTM F 2077 -18 .
. Static Compression-Shear Test - ASTM F 2077 -18
. Static Expulsion Test - ASTM draft F-04.25.02.02
. Static Subsidence Test – ASTM F 2267 – 04 (Reapproved 2018)
. 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-TA Expandable Lumbar Cage System showed a higher or similar mechanical value than predicate marketed devices.

7. MATERIAL

The PathLoc-TA Expandable Lumbar Cage System is manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.

COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 8.

The subject and predicate devices have identical technological characteristics and there is not any new issues of safety and effectiveness. the following characteristics are same between the subject and predicates:

י Instruction for use
י Design and sizes
-Expanding Mechanism
. Material
י Approach
. Sterilization & Method
. Manufacturing process

SUBSTANTIAL EQUIVALENCE AND CONCLUSION 9.

The subject PathLoc-TA Expandable Lumbar Cage System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial

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equivalence of the subject device to the predicate devices.

The overall data lead to the conclusion that the PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to the predicate devices.

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.