OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

Device Description

The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the OrthoPediatrics' PediLoc Fragment System, as presented in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Technological Characteristics	Fundamental scientific principles, intended use, material, general design, and sizes are the same as or similar to predicate devices.	The device's fundamental scientific principles, intended use, material, and general design, and sizes are reported to be the same as, or similar to, the predicate devices.	Comparison with Predicate Devices
Mechanical Performance	Performs as well as or better than predicate devices.	Performed as well as or better than the predicate devices.	Nonclinical (Bench) Testing
Static Testing	Meets established static performance standards.	Demonstrated satisfactory performance as per ASTM Standards.	Nonclinical (Bench) Testing
Dynamic Testing	Meets established dynamic performance standards.	Demonstrated satisfactory performance as per ASTM Standards.	Nonclinical (Bench) Testing
FEA Analysis	Results are comparable or superior to predicate devices.	FEA analysis along with comparisons demonstrated satisfactory performance.	Nonclinical (FEA Analysis)
Dimensional Comparison	Dimensions are comparable and supported by engineering rational.	Dimensional comparison review and analysis with engineering rational provided supportive data.	Nonclinical (Dimensional Review)

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

The provided 510(k) summary does not mention a "test set" in the context of clinical data or human subject studies. The nonclinical testing performed involved mechanical laboratory (bench) testing, FEA analysis, and dimensional comparisons. Therefore, there is no information about a sample size for a test set or data provenance in terms of country of origin or retrospective/prospective nature for human data.

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

There is no mention of experts or a ground truth establishment process for a human-related test set. The study detailed is entirely nonclinical (bench testing and analysis).

4. Adjudication Method for the Test Set

Not applicable, as there was no test set involving human data or expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study presented is nonclinical and focuses on the physical and mechanical properties of the device compared to predicate devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical medical implant (fragment system), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" in the context of algorithms does not apply.

7. The Type of Ground Truth Used

For the nonclinical studies, the "ground truth" was established based on:

ASTM Standards: Recognized industry standards for mechanical testing of medical devices.
Predicate Device Performance: The established performance characteristics of legally marketed predicate devices.
Engineering Rational: Principles of engineering analysis and design for comparison of dimensions and performance.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm or system that requires a "training set" of data.

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

Not applicable, as there was no training set for an algorithm.

Summary

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510(k) Summary

JUL 2 9 2014

NAME OF FIRM:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, IN 46582
DATE PREPARED:	June 16, 2014
510(K) CONTACT:	Mark FoxVice President, Regulatory AffairsTel: (574) 268-6379
PROPOSED TRADENAME:	PediLoc Fragment System
DEVICECLASSIFICATION:	Class II; 21 CFR 888.3030 and 21 CFR 888.3040
CLASSIFICATIONNAME:	Sinqle/multiple component metallic bone fixation appliancesand accessories. Smooth or threaded metallic bone fixationfastener.
PRODUCT CODE:	KTT, HRS, HWC, HTN
DEVICEDESCRIPTION:	The OrthoPediatrics' PediLoc Fragment Systemcombines implants and instruments in one convenientand comprehensive system. This System providesimmediate stability and temporary fixation of bonesduring the healing process with conventional platingtechnology and fixation techniques.
INDICATIONS FORUSE:	OrthoPediatrics' PediLoc Fragment System is intendedto provide temporary internal fixation and stabilization oflong bones, short (small) bones, pelvis, and scapula.This includes fractures, osteotomies, mal-unions, andnon-unions in all pediatric subgroups (except neonates),and small stature adults.
MATERIALS:	Medical grade Stainless SteelMedical grade cobalt-chromium-molybdenum
PREDICATE DEVICES:	OrthoPediatrics Fracture and Osteotomy Bone Plate System(K111086)OrthoPediatrics PediLoc Locking Plate System (K083286)OrthoPediatrics Bone Screws (K082949)Synthes Small Fragment Dynamic Compression Locking(DCL) System (K000684)

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TECHNOLOGIC CHARACTERISTICS:

PERFORMANCE DATA:

NONCLINICAL TESTING:

The fundamental scientific principles and technological characteristics, including the intended use, material, and general design, and sizes of the device are the same as, or similar to, the predicate devices.

Tests performed according to ASTM Standards, demonstrated that the device performs as well as or better than the predicate devices.

Nonclinical testing included mechanical laboratory (bench) testing. Static and dynamic testing in addition to FEA analysis and comparisons of the subject devices with legally marketed predicates identified within this submission were performed. Dimensional comparison review and analysis with engineering rational provided additional nonclinical supportive data. The subject devices performed as well as or better than the predicate devices.

CONCLUSION:

The OrthoPediatrics' PediLoc Fragment System has the same intended use and technological characteristics as the predicate devices. Therefore the OrthoPediatrics' PediLoc Fragment System is substantially equivalent for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES/USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 29, 2014

OrthoPediatrics Corporation Mr. Mark Fox V. P. Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K140431

Trade/Device Name: PediLoc Fragment 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, HWC, HTN, KTT Dated: June 16, 2014 Received: June 17, 2014

Dear Mr. Fox:

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 gencral 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

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Page 2 - Mr. Mark Fox

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/ResourcesforYou/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 yours, Lori A. Wiggins

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

Enclosure

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K140431 - page 1 of 1

Indications for Use Statement

510(k) Number (if known): K140431

Device Name: OrthoPediatrics' PediLoc Fragment System

Indications for Use:

OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unlons, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use

(21 CFR 807 Subpart C) (21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet标志示Frank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140431

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.