Pediatric Plating Platform Hip

K243963 · OrthoPediatrics Corp. · HRS · Apr 29, 2025 · Orthopedic

Device Facts

• Record ID: K243963
• Device Name: Pediatric Plating Platform Hip
• Applicant: OrthoPediatrics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

Device Story

Pediatric Plating Platform | Hip is a bone fixation system consisting of plates, screws, and connector bolts used for proximal femur deformity correction and trauma. The device provides stable fixation and healing through the use of locking and non-locking screws. It is available in various sizes and angles to accommodate infant, child, and adolescent anatomy. The system is intended for use by surgeons in a clinical/surgical setting. The device is manufactured from 316LVM stainless steel. It is MR Conditional. The system is used to stabilize bone segments during the healing process, benefiting patients by facilitating proper bone alignment and recovery.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility assessment based on predicate device history. Mechanical performance evaluated per ASTM F543 (torsional, insertion/removal torque, axial pullout) and ASTM F384 (static compression bending and fatigue). MR compatibility evaluated per ASTM F2052, F2213, F2182, and F2119.

Technological Characteristics

Materials: 316LVM Stainless Steel (ASTM F138/F139). Components: Plates, screws, connector bolts. Mechanical testing standards: ASTM F543, ASTM F384. MR safety standards: ASTM F2052, F2213, F2182, F2119. Device is MR Conditional.

Indications for Use

Indicated for pediatric and small stature adult patients requiring temporary internal fixation and stabilization of proximal femur fractures, osteotomies, mal-unions, and non-unions.

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

• Locking Proximal Femur System (K162307, K111086)
• Compression Hip Screw (CHS) (K210837, K993289)
• Pediatric LCP Hip Plate System (K072095)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 29, 2025

OrthoPediatrics Corp.
Yan Li
Regulatory Affairs Director
2850 Frontier Dr.
Warsaw, Indiana 46582

Re: K243963
Trade/Device Name: Pediatric Plating Platform | Hip
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: HRS, HWC, JDO
Dated: December 20, 2024
Received: December 23, 2024

Dear Yan Li:

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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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 (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 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-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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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, 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243963

Device Name
Pediatric Plating Platform | Hip

Indications for Use (Describe)
The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

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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OrthoPediatrics, Corp.
Pediatric Plating Platform | Hip
Traditional 510(k)
K243963

OrthoPediatrics

# 510(k) Summary

## I. Submitter

Submission: Traditional 510(k) Premarket Notification
Applicant: OrthoPediatrics Corp.
Applicant Address: 2850 Frontier Drive, Warsaw, IN 46582
Establishment Registration Number: 3006460162
Contact: Yan Li
Contact Phone: [phone]
Date Prepared: April 29, 2025

## II. Device

Device Trade Name: Pediatric Plating Platform | Hip
Common Name: Bone Plates and Screws
Device Classification: II
Classification Panel: Orthopedic
Regulation Number: 21 CFR 888.3030
21 CFR 888.3040
Classification Product Code: HRS
HWC
JDO
Device Classification Name: Plate, Fixation, Bone Screw, Fixation, Bone Device, Fixation, Proximal Femoral, Implant

## III. Predicate Device and Reference Device

Primary predicate device:
Locking Proximal Femur System
- Cleared under K162307 and K111086, OrthoPediatrics Corp.

Additional predicate device:
Compression Hip Screw (CHS)
- Cleared under K210837 and K993289, Smith & Nephew, Inc.

Pediatric LCP Hip Plate System
- Cleared under K072095, Synthes

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OrthoPediatrics, Corp.
Pediatric Plating Platform | Hip
Traditional 510(k)
K243963

OrthoPediatrics

## IV. Device Description

The Pediatric Plating Platform | Hip consists of plates, screws and connector bolts in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Hip also includes surgical instruments.

The Pediatric Plating Platform | Hip offers a selection of plates and screws specifically designed for deformity correction and trauma of the proximal femur. Plates are offered in a variety of angles and offsets to accommodate the anatomy following planned osteotomies or fixation of traumatic fractures. The plate is fixed to the bone via the choice of beam, locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Hip is available in infant, child and adolescent families providing a suitable range of screw and plate sizes.

The implants of the Pediatric Plating Platform | Hip are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

## V. Indications for Use

The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

## VI. Comparison of Technological Characteristics

The Pediatric Plating Platform | Hip is substantially equivalent to the primary predicate devices OrthoPediatrics Locking Proximal Femur System in that these devices have the same intended use and principle of operation, and many other similar fundamental technological characteristics. There are some differences between the predicate and subject devices in terms of design and size options. The successful testing data provided in this submission supported that the differences between the subject and predicate devices do not raise new questions for safety and effectiveness.

## VII. Performance Data

The biocompatibility assessment for the Pediatric Plating Platform | Hip were based on the prior use of the OrthoPediatric Corp's Locking Proximal Femur System which share the same materials, same manufacturing and cleaning processes, same geometry and physical properties, as well as same body contact and clinical use.

The implants of Pediatric Plating Platform | Hip were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such.

Mechanical performance evaluations included Torsional Properties, Insertion and Removal Torque, Axial Pullout Strength per ASTM F543 and Static Compression Bending and Fatigue

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OrthoPediatrics, Corp.
Pediatric Plating Platform | Hip
Traditional 510(k)
K243963

OrthoPediatrics

Compression Bending per ASTM F384. Results of the mechanical testing demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate.

## VIII. Conclusion

The information provided above supports that the Pediatric Plating Platform | Hip is as safe and effective as the predicate device. Information and data provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the Pediatric Plating Platform | Hip is substantially equivalent to the predicate device.

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