OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis; and failed previous fusion (pseudoarthrosis).

The OpenLoc-L Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in sketally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OpenLoc-L Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Device Description

This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

AI/ML Overview

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable. The document describes a medical device, the OpenLoc-L Spinal Fixation System, and its substantial equivalence to a predicate device based on mechanical performance testing.

Here's an analysis of the provided text in the context of the device described:

Device Description:
The OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device. It consists of screws, set screws, rods, crosslinks, hooks, and connectors. These components are made from Titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537).

Indications for Use:
The system is intended for use as a posterior pedicle screw fixation system (T1-S2/ilium) or as an anterolateral fixation system (T8-L5) in skeletally mature patients. It is an adjunct to fusion for indications such as degenerative disc disease, spondylolisthesis, trauma, deformities (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion. It is also specifically indicated for severe spondylolisthesis (Grades 3 and 4) of L5-S1 and for immobilization and stabilization of spinal segments in acute and chronic instabilities or deformities.

Predicate Device:
The predicate device is the LnK Spinal Fixation System (K143363).

Acceptance Criteria and Study for a Spinal Fixation System (Mechanical Testing):

Since this is a mechanical device, the acceptance criteria are typically based on established industry standards for mechanical performance, and the study involves bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (based on ASTM F543-13 and comparison to predicate)	Reported Device Performance
General Performance: Substantially equivalent mechanical performance to predicate device (LnK Spinal Fixation System K143363) regarding pullout strength.	Pullout Testing: Results demonstrate substantially equivalent performance to the legally marketed predicate device.
Material Compatibility, Sterility, and Design: Materials (Ti-6Al-4V ELI, Co-Cr-Mo alloy), non-sterile status, and design (screw diameters/lengths, rod diameters/lengths, hook types) should be equivalent to the predicate device.	The subject device utilizes the same materials (ASTM F136 & F1537) and has similar design specifications (screw and rod dimensions, hook types) as the predicate.

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of screws or constructs tested. For mechanical testing per ASTM standards, a sufficient number of samples (e.g., typically 5-10 per test condition, depending on the standard and variability) would be used to achieve statistical significance.
- Data Provenance: The testing was performed in the context of a 510(k) submission, meaning it's pre-market data generated by the manufacturer (L&K BIOMED Co., Ltd.) to demonstrate product safety and effectiveness. The country of origin of the testing lab is not explicitly stated, but the submission is from Korea. The testing would be prospective in the sense that it was conducted specifically for this submission.
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 question is not applicable to mechanical performance testing of a spinal fixation system. "Ground truth" in this context would refer to the physical testing standards (e.g., ASTM F543-13) and engineering principles, not expert clinical interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human interpretation tasks (e.g., image reading) where multiple experts or readers are involved. For mechanical bench testing, the results are quantitative measurements against predefined standards.
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 question for AI/ML device performance, not a mechanical spinal implant. No human readers or AI assistance are involved in evaluating the mechanical performance of a pedicle screw system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML software. The device in question is a physical spinal implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical performance testing, the "ground truth" is defined by the ASTM F543-13 standard for pullout testing. This standard specifies the methodology and acceptable criteria for evaluating the pullout strength of metallic medical bone screws. Substantial equivalence to the predicate device, which would have also demonstrated compliance with such standards, is the benchmark.
The sample size for the training set:
- Not applicable. There is no "training set" for physical mechanical devices. This concept is relevant for AI/ML models.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

In summary, the provided document details a 510(k) submission for a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on mechanical bench testing and comparison to an existing predicate device using recognized industry standards (e.g., ASTM).

Summary

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

L&K BIOMED Co., Ltd. Ms. Yerim An RA Manager #201. 202 16-25. Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA

July 13, 2017

Re: K171813

Trade/Device Name: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: June 16, 2017 Received: June 19, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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 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.

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

510(k) Number (if known) K171813

Device Name

OpenLoc-L Spinal Fixation System, LnK Spinal Fixation 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:	L&K BIOMED Co., Ltd.#201, 202 16-25, Dongbaekjungang-ro 16beon-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015KoreaPhone. 82-2-6717-1985e-mail: yerim2706@Inkbiomed.com
Contact Person:	Yerim An

Date prepared: July, 12, 2017

2. Device Identification

Trade Name	OpenLoc-L Spinal Fixation SystemLnK Spinal Fixation System
Common Name	Spinal Fixation Appliances
Product Code	NKB, KWP, KWQ
Regulatory Class	Class II
Classification Name	Thoracolumbosacral Pedicle Screw System, 21 CFR §888.3070Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060

Purpose of 510(k) 3.

The L&K BIOMED Co. Ltd., here by submits this special 510(k): device modification to request a modification for our previous LnK Spinal Fixation System. The modifications are to add new components and new brand name. We believe these modifications are eligible for the Special 510(k) process since they have the same fundamental scientific technology and intended use as the predicate device.

Predicate or legally marketed devices which are substantially equivalent 4.

LnK Spinal Fixation System K143363

Description of the Device 5.

This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium

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alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

Materials:

Product	Material	Standard
Screw	Ti-6Al-4V ELI	ASTM F136
	Ti-6Al-4V ELI	ASTM F136
Rod	Cobalt-28Chromium-6Molybdenum-4Vanadium ELI	ASTM F1537
Hook	Ti-6Al-4V ELI	ASTM F136
Set Screw	Ti-6Al-4V ELI	ASTM F136
Accessories	Ti-6Al-4V ELI	ASTM F136

Any implant components other than the rods are not manufactured from cobalt chrome.

Indication for Use 6.

OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/illum), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

degenerative disc disease (defined as discogenic back pain with degeneration of . the disc confirmed by history and radiographic studies);
. spondylolisthesis;
. trauma (i.e., fracture or dislocation);
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
tumor: .
. stenosis, and
. failed previous fusion (pseudoarthrosis)

The OpenLoc-L Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OpenLoc-L Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

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7. Comparison of the technological characteristics of the subject and the predicate device

Applicant	L&K BIOMED Co.,Ltd.	L&K BIOMED Co.,Ltd.
DeviceName	OpenLoc-L Spinal Fixation SystemLnK Spinal Fixation System	LnK Spinal Fixation System
	Subject Device	Predicate Device
510K No.		K143363
RegulationNo.	888.3050, 888.3070	888.3050, 888.3070
ProductCode	KWQ,KWP,NKB	MNI, MNH,KWQ,KWP,NKB
Class	Class II	Class II
Material	Titanium alloy (ASTM F136)CoCr Alloy (ASTM F1537)	Titanium alloy (ASTM F136)CoCr Alloy (ASTM F1537)
Sterile	Non-sterile	Non-sterile
Rod	Dia: 5.0/5.5/6.0mm Length:40~600mm	Dia: 5.0/5.5/6.0mm Length:40~600mm
Screw	Dia:4.0~8.5mm Length:20-150mm	Dia:4.0~8.5mm Length:20-150mm
Hooks	Ramped Hook - 6.0 Rod(Narrow,Standard, Wide)General Hook - 6.0 Rod(Narrow,Standard, Wide)Pedicle Hook - 6.0 Rod(Narrow,Standard, Wide)Angled Hook - 6.0 Rod(Right, Left)Offset Hook - 6.0 Rod(Right, Left)	Ramped Hook - 6.0 Rod(Narrow, Standard,Wide)General Hook - 6.0 Rod(Narrow, Standard,Wide)Pedicle Hook - 6.0 Rod(Narrow, Standard,Wide)Angled Hook - 6.0 Rod(Right, Left)Offset Hook - 6.0 Rod(Right, Left)
Indicationfor use	OpenLoc-L Spinal Fixation Systemisnon-cervicalspinal fixation devicesintended for use as posterior pediclescrew fixation systems (T1-S2/ilium), oras an anterolateral fixation system (T8-L5). All components in the system arelimited to skeletally mature patients.These devices are indicated as anadjunct to fusion for all of the followingindications regardless of the intendeduse:degenerative disc disease (defined asdiscogenic back pain with degenerationof the disc confirmed by history andradiographic studies);spondylolisthesis;trauma (i.e., fracture or dislocation);deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis);tumor;stenosis, andfailed previous fusion (pseudoarthrosis)The OpenLoc-L Spinal Fixation Systemis a pedicle screw system indicated forthe treatment of severe	LnK Spinal Fixation System is non-cervicalspinal fixation devices intended for use asposterior pedicle screw fixation systems(T1-S2/ilium), or as an anterolateral fixationsystem (T8-L5). All components in thesystem are limited to skeletally maturepatients. These devices are indicated as anadjunct to fusion for all of the followingindications regardless of the intended use:degenerative disc disease (defined asdiscogenic back pain with degeneration ofthe disc confirmed by history andradiographic studies);spondylolisthesis;trauma (i.e., fracture or dislocation);deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis);tumor;stenosis, and*failed previous fusion (pseudoarthrosis)The LnK Spinal Fixation System is apedicle screw system indicated for thetreatment of severe Spondylolisthesis(Grade 3 and 4) of the L5-S1 vertebra inskeletally mature patients receiving fusion

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The OpenLoc-L Spinal Fixation System shares technological characteristics similar to the predicate device. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.

Performance Testing 8.

Pullout testing per ASTM F543-13 was performed on the subject screws and compared to a legally marketed predicate device. Results of the testing demonstrate substantially equivalent performance.

Conclusion 9.

The OpenLoc-L Spinal Fixation System is substantially equivalent to the device referenced above.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.