The CastleLoc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
. spondylolisthesis,
trauma (i.e. fractures or dislocations), .
tumors, .
. deformity (defined as kyphosis, lordosis, or scoliosis),
failed previous fusion (pseudoarthrosis) .
spinal stenosis. .

Device Description

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are selftapping and self-drilling threaded. This device is provided as non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the CastleLoc-P Anterior Cervical Plate System. It describes the device and claims substantial equivalence to a predicate device based on performance testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Results)
Static compression bending strength	Performed, demonstrated substantial equivalence.
Static tension strength	Performed, demonstrated substantial equivalence.
Static torsion strength	Performed, demonstrated substantial equivalence.
Dynamic compression bending strength (Fatigue performance)	Performed according to ASTM F1717, demonstrated substantial equivalence.

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

The document does not explicitly state the numerical sample size for the mechanical performance tests. It mentions "a worst-case, cervical plate construct," implying a representative sample was tested.

The data provenance is from bench testing conducted by the manufacturer, L&K Biomed Company, Limited. There is no information regarding country of origin for the data beyond the manufacturer's location (Republic of Korea), or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is a premarket notification for a medical device (spinal intervertebral body fixation orthosis) based on mechanical (bench) performance data, not clinical data or data requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical bench testing; there is no adjudication process involving human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (spinal plate system), not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this type of device is established by ASTM (American Society for Testing and Materials) standards for mechanical performance, specifically ASTM F1717 for Spinal intervertebral body fixation orthoses. Compliance with these established industry standards serves as the benchmark for performance.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or AI where a training set would be used. The "training" in this context would refer to the design and engineering process of the device, which doesn't involve a quantifiable "training set" in the computational sense.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device would adhere to engineering principles and regulatory requirements to achieve the desired mechanical properties.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces or heads. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

July 1, 2015

L&K Biomed Company, Limited Ms. Yerim An Regulatory Affairs Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea

Re: K143271

Trade/Device Name: CastleLoc-P Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: June 4, 2015 Received: June 5, 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

{1}------------------------------------------------

Page 2 - Ms. Yerim An

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 vours.

Lori A. Wiggins -S

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

Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K143271 Device Name: CastleLoc-P Anterior Cervical Plate System

Indications For Use:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
. spondylolisthesis,
trauma (i.e. fractures or dislocations), .
tumors, .
. deformity (defined as kyphosis, lordosis, or scoliosis),
failed previous fusion (pseudoarthrosis) .
spinal stenosis. .

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 (CDRH)

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K143271

{3}------------------------------------------------

K143271 - Page 1 of 2

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:	June, 05, 2015
2.	Device Identification
	Trade Name	CastleLoc-P Anterior Cervical Plate System
	Common Name	Anterior Cervical Plate
	Product Code	KWQ
	Classification Name	Spinal Intervertebral Body Fixation Orthosis(21 CFR888.3060)
	Classification	Class II

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

■ Primary predicate device : L&K Biomed_LnK Anterior Cervical Plate System (K113509)

4. Description of the Device

{4}------------------------------------------------

5. Intended use

. degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis,
. trauma (i.e. fractures or dislocations),
tumors,
. deformity (defined as kyphosis, lordosis, or scoliosis),
failed previous fusion (pseudoarthrosis)
spinal stenosis. .

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

There are no significant differences between the LnK Anterior Cervical Plate System and CastleLoc-P Anterior Cervical Plate System and other systems currently being marketed which would not adversely affect the use of the product. It is substantially equivalent to these other devices in design, function and intended use.

7. Performance Data

Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing.

8. Conclusion

The CastleLoc-P Anterior Cervical Plate System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.