CastleLoc Pectus Bar System

K260448 · L&K BIOMED Co., Ltd. · HRS · Mar 19, 2026 · Orthopedic

Device Facts

• Record ID: K260448
• Device Name: CastleLoc Pectus Bar System
• Applicant: L&K BIOMED Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 19, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 Story

Thoracic support system for surgical repair of pectus excavatum and anterior chest wall deformities; utilizes minimally invasive techniques to elevate ribs and sternum. System comprises various sizes of straight and curved metallic bars, stabilizers, nuts, and claw fixators. Implantation typically lasts 2-3 years per surgeon preference. Device provides structural support to maintain chest wall correction. Used in clinical/surgical settings by surgeons.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via engineering analysis and comparison to predicate data (Static 4-Point Bending, Dynamic 4-Point Bending, and Vertical Tensile Tests per ASTM F382-17). No clinical data required.

Technological Characteristics

Materials: Ti-6Al-4V (ASTM F136). Components: Pectus bars (straight/curved), stabilizers, nuts, claw fixators. Mechanical fixation principle. Dimensions vary by patient size. No software or energy source.

Indications for Use

Indicated for treatment of Pectus Excavatum and other anterior chest deformities in pediatric (children and adolescents) and adult populations.

Regulatory Classification

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.

Predicate Devices

• CastleLoc Pectus Bar System (K250892)
• CastleLoc Pectus Bar System (K243357)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 19, 2026

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
Republic Of Korea

Re: K260448
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: February 11, 2026
Received: February 11, 2026

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260448 - Kihyang Kim
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K260448 - Kihyang Kim
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.
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

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K260448 | ? |
| Please provide the device trade name(s). | | ? |
| CastleLoc Pectus Bar System | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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510(k) #: K260448
510(k) Summary
Prepared on: 2026-03-17

| 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, Republic of |
| Applicant Contact Telephone | 82-10-5477-0325 |
| Applicant Contact | Ms. Kihyang Kim |
| Applicant Contact Email | [e-mail] |
| 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) |
| K250892 | CastleLoc Pectus Bar System |
| K243357 | CastleLoc Pectus Bar System |
| Product Code | HRS |
| Device Description Summary | 21 CFR 807.92(a)(4) |
| 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 appropriate 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). | |
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
| 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. | |
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
| The indications for use of the subject CastleLoc Pectus Bar System are the same as those of the primary predicate device, CastleLoc Pectus Bar System (K250892). In addition, the intended use of the subject device is also the same as that of the additional predicate device, CastleLoc Pectus Bar System (K243357). Therefore, both the predicate devices and the subject device are intended for the | |

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treatment of pectus excavatum and other chest wall deformities.

| Technological Comparison | 21 CFR 807.92(a)(6) |
| --- | --- |
| The subject CastleLoc Pectus Bar System includes additional pectus bars and components with various dimensions (including shorter and longer lengths and curvatures) compared to the legally marketed predicate devices, CastleLoc Pectus Bar System (K243357 and K250892). An engineering analysis was also performed for the subject CastleLoc Pectus Bar System, which demonstrated that the design modifications of the subject device do not represent a worst-case condition relative to the predicate devices. The design characteristics and indications for use of the subject device system are substantially equivalent to those of the predicate devices. In addition, the subject device and the predicate devices (K243357 and K250892) are the same with respect to materials, manufacturing process, design, indications for use, intended use, and operational principles. | |
| Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) |
| The subject CastleLoc Pectus Bar System was compared with the legally marketed predicate devices, CastleLoc Pectus Bar System (K243357 and K250892), to confirm worst-case justification. Mechanical bench testing of the predicate CastleLoc Pectus Bar System was conducted in accordance with ASTM F382-17, including Static 4-Point Bending, Dynamic (fatigue) 4-Point Bending, and Vertical Tensile Tests. An engineering analysis was also performed for the subject CastleLoc Pectus Bar System, which demonstrated that the design modifications of the subject device do not represent a worst-case condition relative to the predicate devices. Therefore, no additional performance testing was required. Based on these results, the subject CastleLoc Pectus Bar System demonstrates substantially equivalent mechanical performance compared to the predicate devices, and the information provided in this 510(k) submission supports a determination of substantial equivalence. | |