K Number

Device Name

CastleLoc Pectus Bar System

Manufacturer

L&K BIOMED Co., Ltd.

Date Cleared

2025-02-27

(121 days)

Product Code

HRS

Regulation Number

888.3030

Intended Use

The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

Device Description

The CastleLoc Pectus Bar System is a thoracic support product that repairs the thoracic wall, using minimally invasive surgical techniques to elevate the ribs and sternum to correct a type of chest wall deformity called pectus excavatum. Recommended implantation time is 2~3 years but may vary based on surgeon preference and patient. This system includes various sizes of straight and curved CastleLoc Pectus Bars. The apropriate bar is selected based on suitability for the patient body size. The CastleLoc Pectus Bar, and Castleloc Pectus Stabilizer, Nut and Castleloc Pectus Claw Fixator for fixing the Castleloc Pectus Bar are made of Ti-6Al-4V (ASTM F136).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K191057, K241709, K221938

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant system for correcting chest deformities and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
This device is a therapeutic device because its intended use is for the treatment of Pectus Excavatum and other anterior chest deformities by repairing the thoracic wall and elevating the ribs and sternum.

Diagnostic

Explanation: The device is a surgical implant designed to correct physical deformities of the chest wall. Its purpose is therapeutic (repairing the thoracic wall), not diagnostic (identifying or characterizing a medical condition).

SaMD (Software as a Medical Device)

The device description explicitly states that the system includes physical components made of Ti-6Al-4V (ASTM F136), such as bars, stabilizers, nuts, and fixators, which are implanted into the patient. This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The CastleLoc Pectus Bar System is a surgical implant used to physically repair the thoracic wall and correct a chest wall deformity. It is a structural device implanted within the body.
Intended Use: The intended use is the treatment of Pectus Excavatum and other anterior chest deformities through surgical intervention.

The device's function is mechanical and structural, not diagnostic based on analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

HRS

Device Description

This system includes various sizes of straight and curved CastleLoc Pectus Bars. The apropriate bar is selected based on suitability for the patient body size. The CastleLoc Pectus Bar, and Castleloc Pectus Stabilizer, Nut and Castleloc Pectus Claw Fixator for fixing the Castleloc Pectus Bar are made of Ti-6Al-4V (ASTM F136).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic wall, ribs, sternum, chest

Indicated Patient Age Range

pediatric (children and adolescents) and adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical and/or Clinical Tests Summary & Conclusions: These tests verified the mechanical performance of the CastleLoc Pectus Bar system according to ASTM F382-17 standards. Side-by-side comparison of the CastleLoc-Pectus Bar system test results for the Park's Pectus System (K191057) was conducted. The mechanical performance test results of the CastleLoc-Pectus Bar system were shown to be similar or higher than the predicate device, Park's Pectus System (KI 91057), and meets the specified acceptance criteria.

Therefore, this test report support that the CastLloc-Pectus Bar system has substantially equivalent mechanical performance as compared to the predicate device, and support that the subject device is at least as safe and effective as the predicate. It is concluded that the information provided in this 510(k) submission supports substantial equivalence

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191057, K241709, K221938

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services seal. To the right of the seal is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 27, 2025

L&K BIOMED Co., Ltd. Kihyang Kim Vice Chairman #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 South Korea

Re: K243357

Trade/Device Name: CastleLoc Pectus Bar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: January 24, 2025 Received: January 27, 2025

Dear Kihyang 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

Submission Number (if known)

K243357

Device Name

CastleLoc Pectus Bar 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) #: K243357	510(k) Summary	Prepared on: 2025-02-27
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	L&K BIOMED Co., Ltd.
Applicant Address	#101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu,
Yongin-si Gyeonggi-do 17015 Korea, South
Applicant Contact Telephone	82-10-5477-0325
Applicant Contact	Ms. Kihyang Kim
Applicant Contact Email	khkim@Inkbiomed.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	CastleLoc Pectus Bar System
Common Name	Single/multiple component metallic bone fixation appliances and
accessories
Classification Name	Plate, Fixation, Bone
Regulation Number	888.3030
Product Code(s)	HRS
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K191057	Park's Pectus System	HRS
K241709	Pectus Blu Support Bar System	HRS
K221938	KLS Martin Pure Pectus System	HRS
Device Description Summary		21 CFR 807.92(a)(4)

Intended Use/Indications for Use

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject CastleLoc Pectus Bar System have been found to be substantially equivalent to the predicate devices with respect to technological characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject CastleLoc Pectus Bar System to the predicate devices.

Technological Comparison

21 CFR 807.92(a)(6)

The CastleLoc Pectus Bar System has undergone a comprehensive battery of non-clinical performance testing, to include static and dynamic 4-point bending test and vertical test. Based on the test result the CastlLloc Pectus Bar System is suitable for its intended use and the test results also supports substantial equivalence of the CastleLoc Pectus Bar System to the primary predicate Park's Pectus System (K191057)

The design feature and indications for use of the subject devices are substantially equivalent to the predicate devices. Primary Predicate Device: Park's Pectus System (K191057) Additional Predicate Device: Pectus Blu Support Bar System (K241709) KLS Martin Pure Pectus System (K221938)

The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use, intended use and operational principles.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

These tests verified the mechanical performance of the CastleLoc Pectus Bar system according to ASTM F382-17 standards. Side-by-side comparison of the CastleLoc-Pectus Bar system test results for the Park's Pectus System (K191057) was conducted. The mechanical performance test results of the CastleLoc-Pectus Bar system were shown to be similar or higher than the predicate device, Park's Pectus System (KI 91057), and meets the specified acceptance criteria.