The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.

Device Description

The OrthoPediatrics Locking Proximal Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.

AI/ML Overview

The FDA 510(k) summary for the OrthoPediatrics Locking Proximal Femur System Cortical Screws (K162307) describes the device as a line extension to an existing system, adding longer cortical screws. The submission focuses on demonstrating substantial equivalence to a predicate device (K111086).

Based on the provided document, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	The proposed device's intended use must be the same as the predicate device: temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults.	The proposed Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults, which is the same as the predicate device.
Indications for Use	The proposed device's specific indications for use must be identical to the predicate device: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.	The proposed Locking Proximal Femur System Cortical Screws Indications for Use are identical to the predicate devices.
Material Equivalence	The proposed device's implant material must be identical to the predicate system's screws (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard).	The proposed Locking Proximal Femur System Cortical Screws use the identical implant material as the predicate system's screws (medical grade BIODUR stainless steel which meets ASTM 2229-07 standard).
Design Features	The proposed device's design features must be similar to the predicate system's screws, accommodating differences like screw length and change from cannulated to solid. Safety and performance should remain equivalent.	The proposed Locking Proximal Femur System Cortical Screws incorporate similar design features as the predicate system's screws with the difference being the length of the screw and the change from cannulated to solid. The submission implies that these differences do not introduce new risks or reduce performance.
Sterilization	The proposed device's sterilization state must be identical to the predicate device (non-sterile).	The proposed Locking Proximal Femur System Cortical Screws are provided non-sterile, which is identical to the predicate device.
Performance (Non-Clinical)	Engineering analysis must demonstrate substantial equivalence between the subject device and the predicate device, implying that the mechanical performance (e.g., strength, durability, fixation capability) is maintained despite changes in length and cannulation.	Engineering analysis was performed to show substantial equivalence between the subject device and predicate device. The document does not provide specific metrics or results from this engineering analysis, but states that the activities were "verification activities." It also concludes "No new risks have been identified."
Clinical Performance	No clinical performance criteria were explicitly defined for this 510(k) as the submission claims substantial equivalence without new clinical data. The expectation is that clinical performance would be equivalent to the predicate.	Clinical Tests - None provided as a basis for substantial equivalence.

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

Test Set Sample Size: Not applicable in the context of this 510(k). The submission relies on engineering analysis rather than a test set of data from patients or a defined clinical/biomedical dataset. No specific number of samples (e.g., implants tested) from the engineering analysis is provided in the summary.
Data Provenance: Not applicable for a clinical or retrospective/prospective study. The provenance is from engineering analysis data generated by the manufacturer.

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

Not applicable. There was no test set requiring expert ground truth establishment in a clinical or image-based context. The "ground truth" for the engineering analysis would be the established engineering and materials standards (e.g., ASTM 2229-07) and the performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not conducted nor mentioned. This device is a bone fixation screw, not an AI or diagnostic imaging device that would typically involve a multi-reader study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an algorithm or AI device. The "standalone" performance refers to the device's mechanical integrity as an implant. The engineering analysis conducted would assess this, but it's not described as a "standalone study" in the AI/algorithm sense.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering and Material Standards: Compliance with ASTM 2229-07 for material (BIODUR stainless steel).
Predicate Device Characteristics: The known, legally marketed characteristics and performance of the K111086 OrthoPediatrics Locking Proximal Femur System, which serves as the benchmark for substantial equivalence.
Design Specifications: The detailed design of the new screws compared to the predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that involves a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary of the "Study" to Prove Acceptance Criteria:

The "study" conducted to prove the device meets acceptance criteria was an engineering analysis. This analysis compared the proposed Locking Proximal Femur System Cortical Screws (which are a line extension with longer screw sizes and a change from cannulated to solid design) to the predicate device (K111086).

The rationale for substantial equivalence was based on demonstrating similar:

Intended Use
Indications for Use
Materials (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard)
Sterilization (provided non-sterile)
Design Features (with considerations for the length and cannulation differences, implying these differences do not compromise performance).

The submission explicitly states:

"Engineering analysis was performed to show substantial equivalence between the subject device and predicate device."
"Clinical Tests - None provided as a basis for substantial equivalence."

The conclusion is that OrthoPediatrics believes the new screws are substantially equivalent to the predicate based on these similarities and the results of the verification activities (i.e., the engineering analysis), and that no new risks have been identified.

Summary

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

September 27, 2016

OrthoPediatrics, Corp. Mr. Adam Cargill Regulatory Affairs Associate Manager 2850 Frontier Drive Warsaw, Indiana 46582

Re: K162307

Trade/Device Name: OrthoPediatrics Locking Proximal Femur System Cortical Screws 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 Dated: September 1, 2016 Received: September 2, 2016

Dear Mr. Cargill:

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 Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

Mark N. Melkerson -S

Mark N. Melkerson Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162307

Device Name

OrthoPediatrics Locking Proximal Femur System Cortical Screws

Indications for Use (Describe)

The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.

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

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Locking Proximal Femur System Screws Special 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, IN 46582Establishment Registration Number: 9102640Phone: (574) 267-6379Fax: (574) 269-3692
Contact:	Adam CargillRegulatory Affairs Associate Manager
Date:	September 26, 2016
Subject Device:	Trade Name: OrthoPediatrics Locking Proximal Femur System Cortical Screws
	Regulation Number: 888.3030Regulation Name: Single/multiple component metallic bone fixation applianceand accessoriesProduct Code: HRS
	Regulation Number: 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastenerProduct Code: HWC
	Common Name(s): Plate, Fixation, BoneScrew, Fixation, Bone

Legally marketed devices to which substantial equivalence is claimed:

K111086 – OrthoPediatrics Locking Proximal Femur System

Device Description

Materials: The cannulated screws are manufactured from medical grade BIODUR stainless steel ● which meet ASTM 2229-07 standard.
. Function: The system, which includes the cortical screws, functions to provide immediate stability and temporary fixation during the natural healing process.

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Intended Use and Indications for Use

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing, and indications) of the Locking Proximal Femur System Cortical Screws are similar to the predicate system's screws.

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: The proposed Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, malunions, and non-unions, in pediatric and small stature adults which is the same as the predicate device.

Indications for Use: The proposed Locking Proximal Femur System Cortical Screws Indications for Use are identical to the predicate devices.

Materials: The proposed Locking Proximal Femur System Cortical Screws use the identical implant material as the predicate system's screws.

Design Features: The proposed Locking Proximal Femur System Cortical Screws incorporate similar design features as the predicate system's screws with the difference being the length of the screw and the change from cannulated to solid.

Sterilization: The proposed Locking Proximal Femur System Cortical Screws are provided nonsterile, which is identical to the predicate device.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- Engineering analysis was performed to show substantial equivalence between the o subject device and predicate device.
. Clinical Tests - None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

OrthoPediatrics believes that the Locking Proximal Femur System Cortical Screws are substantially equivalent to the legally marketed predical screws (K111086) based on the similarities of design, intended use, materials, and the results of verification activities conducted. No new risks have been identified and it is expected that the Locking Proximal Femur System Cortical Screws will perform substantially equivalent to the legally marketed predicate device.

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.