LnK 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. LtK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The LnK Lumbar Interbody Fusion Cage System is intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. The Tantalum marker used for this product is made to the voluntary standard of ASTM F560. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. LnK Lumbar Interbody Fusion Cage System Implants are single-use devices. They have to be used in a healthcare setting or a hospital.

The LnK PLIF PEEK Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left).

The LnK T-PLIF PEEK Cages which is used in transforaminal posterior lumbar interbody fusion technique. One T-PLIF cage is implanted in interbody space.

The LnK TLIF PEEK Cages are a "banana" shaped. Implants are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.

The LnK ALIF PEEK Cages are to be implanted via anterior approach.

The LnK DLIF PEEK Cages (LnK LLIF PEEK Cages/LnK Lateral PEEK Cages) are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage (LnK LLIF PEEK Cage/LnK Lateral PEEK Cage) can be used in an open approach and a percutaneous approach with MIS instrumentation.

The LnK ATP PEEK Cages are to be implanted via anterior lateral approach.

AI/ML Overview

This document is a 510(k) premarket notification for the LnK Lumbar Interbody Fusion Cage System. It describes a medical device, which is an implant, and therefore the acceptance criteria and supporting studies are related to the physical and mechanical performance of the device itself, rather than diagnostic accuracy or human performance with AI assistance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table form that matches typical AI/ML device evaluations (e.g., sensitivity, specificity thresholds). Instead, for this type of medical implant, the criteria are adherence to ASTM standards and demonstrating mechanical performance equivalent to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with relevant ASTM standards for intervertebral body fusion devices (F2077, F2267).	The LnK Lumbar Interbody Fusion Cage System was tested according to: - Static and Dynamic Axial Compression per ASTM F2077 - Static and Dynamic Compression-Shear Testing per ASTM F2077 - Static and Dynamic Torsion Testing per ASTM F2077 - Static Subsidence testing under Axial Compression per ASTM F2267 - Expulsion Testing (standard not specified, but implied)
Mechanical performance of additional components (new variations of the cage) must be equivalent to the predicate device (K151140).	Finite Element Analysis (FEA) was performed to demonstrate that the `additional components` (new cage variations) do not introduce a new worst case in terms of mechanical performance. The mechanical test data of the primary predicate (K151140) was leveraged to demonstrate the performance of the subject components, indicating that the new components meet the same performance characteristics as the predicate device.
Material compliance for PEEK and Tantalum.	Fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. Tantalum marker made to the voluntary standard of ASTM F560.
Sterilization (Gamma) does not affect device performance.	Stated that "It is widely known that gamma sterilization does not affect the performance of the device." Therefore, only mechanical test data of non-sterilized cages was provided.

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

This is not applicable in the context of an AI/ML device testing. For an implant, the "test set" would refer to the number of physical devices or models subjected to mechanical testing. The document does not specify a numerical sample size (e.g., number of cages tested) for the mechanical performance tests.

Provenance: The tests were conducted on the physical devices (the LnK Lumbar Interbody Fusion Cage System) and their additional components. The materials (PEEK and Tantalum) are described by ASTM standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable. Ground truth in this context refers to the physical and mechanical properties of the implant, which are determined by engineering tests and adherence to established standards, not by expert interpretation of images or clinical data.

4. Adjudication Method

This is not applicable for a mechanical implant device. Adjudication methods like "2+1" are used in diagnostic studies to resolve disagreements among human readers or algorithms.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These studies are typically used for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI assistance on human reader performance. This document describes an implantable medical device.

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

This is not applicable. This device is an implanted medical device, not an AI algorithm. Its "performance" is mechanical and biocompatible, not computational.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and mechanical testing according to recognized industry standards (ASTM) and finite element analysis (FEA), demonstrating that the device meets specific physical requirements and is functionally equivalent to a previously cleared predicate device. Material specifications also form part of the ground truth.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI/ML device that requires a training set.

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

This is not applicable as this is not an AI/ML device that requires a training set.

Summary

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L&K BIOMED Co., Ltd. Jihyeon Seo RA Associate #201, 202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015 Korea

Re: K181380

Trade/Device Name: LnK 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: August 23, 2018 Received: August 23, 2018

Dear Ms. Seo:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

September 11, 2018

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181380

Device Name

LnK 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)

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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:	Gook Jin KangL&K BIOMED Co., Ltd.#201, 202 16-25, Dongbaekjungang-ro 16 beon-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015, KoreaPhone. 82-2-6717-1983FAX .82-2-6717-1949
	Contact Person:	Jihyeon Seo
	Date prepared:	August 28, 2018

2. Device Identification

Trade Name	LnK Lumbar Interbody Fusion Cage System
Common Name	Lumbar Interbody Fusion Cage System
Product Code	MAX
Regulatory Class	II
Classification Name	Intervertebral body fusion device (21 CFR 888.3080)

Predicate or legally marketed devices which are substantially equivalent 3.

The design feature and indications for use for the subject LnK Lumbar Interbody Fusion Cage System is substantially equivalent to the following predicates:

Unmodified device (predicate): LnK Lumbar Interbody Fusion Cage System (K151140) ●

Description of the Device 4.

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The LnK PLIF PEEK Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left).

The LnK T-PLIF PEEK Cages which is used in transforaminal posterior lumbar interbody fusion technique. One T-PLIF cage is implanted in interbody space.

The LnK ALIF PEEK Cages are to be implanted via anterior approach.

The LnK ATP PEEK Cages are to be implanted via anterior lateral approach.

5. Indication for use

LnK 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. LnK 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.

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No	Item	Subject device	Predicate device
		LnK Lumbar Interbody FusionCage System	LnK Lumbar Interbody FusionCage System
1	Manufacturer	L&K BIOMED Co., Ltd.	L&K BIOMED Co., Ltd.
2	Material	PEEK and Tantalum	PEEK and Tantalum
3	510(K) Number		K151140
4	Product Code	MAX	MAX
5	Class	Class II	Class II
6	Sterility	Non-sterile, Sterile	Non-sterile
7	Intended Use	LnK Lumbar InterbodyFusion Cage System isindicated for intervertebralbody fusion procedures inskeletally mature patients withdegenerative disc disease(DDD) at one or twocontiguous levels from L2-S1.DDD is defined as discogenicback pain with degenerationof the disc confirmed bypatient history andradiographic studies. TheseDDD patients may also haveup to Grade 1spondylolisthesis orretrolisthesis at the involvedlevel(s).This device is to beused with autogenous bonegraft. LnK Lumbar InterbodyFusion Cage System is to beused with supplementalfixation. Patients should haveat least six (6) months of non-operative treatment prior totreatment with anintervertebral cage.	LnK Lumbar InterbodyFusion Cage System isindicated for intervertebralbody fusion procedures inskeletally mature patients withdegenerative disc disease(DDD) at one or twocontiguous levels from L2-S1.DDD is defined as discogenicback pain with degenerationof the disc confirmed bypatient history andradiographic studies. TheseDDD patients may also haveup to Grade 1spondylolisthesis orretrolisthesis at the involvedlevel(s).This device is to beused with autogenous bonegraft. LnK Lumbar InterbodyFusion Cage System is to beused with supplementalfixation. Patients should haveat least six (6) months of non-operative treatment prior totreatment with anintervertebral cage.

6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

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	Current	Previous
	PLIF, T-PLIF, TLIF, ALIF, DLIF, ATP PEEK Cage	PLIF, T-PLIF, TLIF, ALIF, DLIF Cage
	Width: 11~~65mmLength: 11~~33mmHeight: 6~~19mmLordosis: 0°~~ 30°	Width: 11~~65mmLength: 11~~32mmHeight: 6~~19mmLordosis : 0°~~ 14°

7. Performance Data

Mechanical performance of additional components is same with the predicate device (K151140). We performed finite element analysis to demonstrate that the additional components do not introduce a new worst case in terms of mechanical performance. Therefore, we leveraged the mechanical test data of the primary predicate (LnK Lumbar Interbody Fusion Cage System, K151140) to demonstrate the performance of the subject components. It is widely known that gamma sterilization does not affect the performance of the device. Therefore, only mechanical test data of non-sterilized cages was provided.

The LnK Lumbar Interbody Fusion Cage System was tested according to the relevant standards, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing per ASTM F2077, Static Subsidence testing under Axial Compression, per ASTM F2267, and Expulsion Testing and .

Conclusion 8.

The additional components of LnK Lumbar Interbody Fusion Cage System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of LnK Lumbar Interbody Fusion Cage System are substantially equivalent to the predicate device (K151140).

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.