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.

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 supplied as sterile or non-sterile.

The LnK PLIF PEEK Cages are to be implanted via posterior approach. These devices are placed two implants 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. However, this kind of cage is to be implanted only one implant on 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 are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage can be used in an open approach and a percutaneous approach with MIS instrumentation.

AI/ML Overview

This document describes the LnK Lumbar Interbody Fusion Cage System, which is a medical device. The information provided focuses on its substantial equivalence to previously marketed devices, rather than a study proving the device meets specific acceptance criteria through clinical performance.

Therefore, many of the requested categories for describing acceptance criteria and a study that proves the device meets them, especially those related to AI algorithm performance or clinical trials with human readers, are not applicable to this 510(k) summary as it is for a physical medical implant device.

However, I can extract information regarding the performance data that was presented to establish substantial equivalence.

This document describes the LnK Lumbar Interbody Fusion Cage System and asserts its substantial equivalence to a predicate device (primary predicate: LnK Lumbar Interbody Fusion Cage System K121096). The performance claim is based on mechanical testing, not a clinical study involving human readers or AI performance.

Here's the breakdown of the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from generally accepted standards for interbody fusion cages)	Reported Device Performance (as stated in the 510(k) summary)
Mechanical Performance: Resistance to static and dynamic axial compression (per ASTM F 2077)	LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Axial Compression. Mechanical performance of additional components is "same with predicated (K121096)."
Mechanical Performance: Resistance to static and dynamic compression-shear (per ASTM F 2077)	LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Compression-Shear Testing. Mechanical performance of additional components is "same with predicated (K121096)."
Mechanical Performance: Resistance to static and dynamic torsion (per ASTM F 2077)	LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Static and Dynamic Torsion Testing. Mechanical performance of additional components is "same with predicated (K121096)."
Mechanical Performance: Resistance to expulsion (per ASTM F 2077)	LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2077. This included Expulsion Testing. Mechanical performance of additional components is "same with predicated (K121096)."
Mechanical Performance: Resistance to static subsidence under axial compression (per ASTM F 2267)	LnK Lumbar Interbody Fusion Cage System was tested according to ASTM F 2267. This included Static Subsidence testing under Axial Compression. Mechanical performance of additional components is "same with predicated (K121096)."
Material Compatibility: Use of established biocompatible materials	Fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. Tantalum marker made to ASTM F560. Materials are the same as the predicate devices.
Functional Equivalence: Device design and indications for use are substantially equivalent to marketed devices.	The design features and indications for use for the subject device are substantially equivalent to the predicate devices (K121096 and K110783).

Note: The document states that the mechanical performance of additional components is the "same with predicated (K121096)" and that "additional sizes are not worst case." This implies that direct testing data for the exact configuration of the new device showing it meets specific numerical thresholds of ASTM F2077 and F2267 is not explicitly detailed, but rather, equivalence is drawn from the predicate's performance and the nature of the "additional components" and sizes.

2. Sample size used for the test set and the data provenance

Test Set Description: Not a "test set" in the context of an algorithm or clinical trial. The "test" refers to mechanical testing of the physical device.
Sample Size: Not specified in terms of number of devices tested, but the testing was done on the "LnK Lumbar Interbody Fusion Cage System" and its "additional components."
Data Provenance: The tests were conducted according to established ASTM standards (ASTM F 2077 and ASTM F 2267). The origin of this specific test data (e.g., in-house testing, third-party lab) is not mentioned beyond stating the company performed or submitted results for the device. The data is retrospective in the sense that it represents completed mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical device being evaluated for mechanical properties and substantial equivalence, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not Applicable. Mechanical tests of physical devices do not typically involve adjudication in this manner. Compliance with ASTM standards, which have defined methodologies and acceptance criteria, is the basis.

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

Not Applicable. This is a physical intervertebral body fusion device, not an AI or diagnostic tool.

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

Not Applicable. This is a physical intervertebral body fusion device, not an AI or diagnostic tool.

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

Mechanical Performance Ground Truth: Compliance with established ASTM standards (ASTM F 2077 and ASTM F 2267) for intervertebral body fusion devices. These standards define the testing methodology and the expected mechanical behavior for such devices, serving as the "ground truth" for mechanical properties.
Substantial Equivalence Ground Truth: The features and performance relative to the predicate device (K121096), which has already received regulatory clearance based on similar, previously accepted performance criteria.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a physical device being mechanically tested, not an algorithm.

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

Not Applicable. There is no "training set" as this is a physical device being mechanically tested, not an algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2015

L&K BIOMED Co., Ltd Ms. Yerim An RA Specialist #201, 202 16-25, Dongaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea

Re: K151140

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: July 17, 2015 Received: July 20, 2015

Dear Ms. An:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Ms. Yerim An

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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 Statement

510(k) Number (if known): K151140 Device Name: LnK Lumbar Interbody Fusion Cage System

Indications For Use:

Prescription Use (Part 21 CER801 Subpart D)

AND/OR

Over-The-Counter Use (21 CER801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OED)

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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, 446-916,KoreaPhone. 82-2-6717-1985FAX .82-2-6717-1989
	Contact Person:	Yerim An
	Date prepared:	Aug. 13, 2015

2. Device Identification

Trade Name	LnK Lumbar Interbody Fusion Cage System
Common Name	Intervertebral Body Fusion Device
Product Code	MAX
Classification Name	Intervertebral body fusion device (888.3080)

3. Predicate or legally marketed devices which are substantially equivalent

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

. Primary Predicate: LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd (K121096)
. Additional Predicate: LnK Lumbar Interbody Fusion Cage System_ L&K BIOMED Co., Ltd (K110783)

Description of the Device 4.

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are supplied as sterile or non-sterile.

The LnK PLIF PEEK Cages are to be implanted via posterior approach. These devices are placed two implants 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. However, this kind of cage is to be implanted only one implant on interbody space.

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

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

5. Indication for use

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No	Item	LnK Lumbar Interbody Fusion	LnK Lumbar Interbody Fusion
		Cage System	Cage System (Predicate)
1	Manufacturer	L&K BIOMED Co., Ltd.	L&K BIOMED Co., Ltd.
2	Material	PEEK and Tantalum	PEEK and Tantalum
3	510(K) Number		K121096
4	Product Code	MAX	MAX
5	Class	ClassII	ClassII
6	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

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

7. Performance Data

Mechanical performance of additional components is same with predicated (K121096). Additional sizes are not worst case. Therefore, We substitute mechanical test data of additional components of LnK Lumbar Interbody Fusion Cage System with it of LnK Lumbar Interbody Fusion Cage System(K121096).

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The LnK Lumbar Interbody Fusion Cage System was tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.

Conclusion 8.

The additional components of LnK Lumbar Interbody Fusion Cage System are substantially equivalent to the device.

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.