The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Device Description

A pediatric small fragment set offers advantages of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non-locking screws Pedi-Loc will offer a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur. Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

AI/ML Overview

The provided text is a 510(k) summary for the OrthoPediatrics PediLoc™ Locking Plate System. This document outlines the general characteristics and intended use of a medical device and its substantial equivalence to previously marketed predicate devices. It does not contain acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets specific performance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it pertains to clinical study design and results, which are not part of this 510(k) summary.

Here's what can be gathered, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not describe performance acceptance criteria or report device performance in the context of a study. 510(k) summaries primarily focus on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and intended use, rather than presenting new clinical performance data with acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No study or ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No study or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This device is a mechanical bone fixation system, not an AI or imaging device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. As above, this is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No study or ground truth is mentioned.

8. The sample size for the training set

Cannot be provided. No training set is mentioned.

9. How the ground truth for the training set was established

Cannot be provided. No training set or ground truth is mentioned.

What can be extracted from the document:

Device Name: OrthoPediatrics PediLoc™ Locking Plate System
Intended Use/Indications: For pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Materials: 316L stainless steel meeting ASTM-F138 standard.
Function: Provides immediate stability and temporary fixation during the natural healing process.
Basis for Substantial Equivalence: Similarities in design, materials, and indications to legally marketed predicate devices (S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA)).

Summary

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K083286 (pg. 10

JAN 30 2009

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	OrthoPediatrics, Corp.210 N. Buffalo StreetWarsaw, Indiana 46580Establishment Registration No.: 9102640
510(K) CONTACT:	Gary BarnettVP-Regulatory & Medical AffairsTel: (574) 268-6379Fax: (574) 269-3692
TRADE NAME:	OrthoPediatrics PediLocTM Locking Plate System
COMMON NAME:	Bone Plates and Bone Screws
CLASSIFICATION:	21 CFR 888.3030: Single/Multiple componentsmetallic bone fixation appliances and accessories:Class II per 21 CFR §888.3030

DEVICE PRODUCT CODE(S): HRS and HWC

SUBSTANTIALLY EQUIVALENT DEVICES:

S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA)

DEVICE DESCRIPTION:

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083286 (pg. 2 of 2)

extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Materials: The devices are manufactured from 316L stainless steel which . meets the ASTM-F138 standard.
. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

INDICATIONS FOR USE:

BASIS FOR SUBSTANTIAL EQUIVALENCE:

OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2009

OrthoPediatrics Corp. C/o Mr. Gary D. Barnett V.P. Regulatory & Medical Affairs 210 North Buffalo Street Warsaw, Indiana 46580

Re: K083286

Trade/Device Name: OrthoPediatrics PediLoc™ Locking Plate 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 Dated: November 5, 2008 Received: November 5, 2008

Dear Mr. Barnett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Gary D. Barnett

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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510(k) Number (if known): K083286

Device Name: OrthoPediatrics PediLoc ™ Locking Plate System

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Numbe

Page 1 of 1

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.