The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

Device Description

OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel.

Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

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

Here's an analysis of the acceptance criteria and study information based on the provided document:

Analysis of Acceptance Criteria and Study for OrthoPediatrics PediNail™ Intramedullary Nailing System (K083726)

This 510(k) submission for the OrthoPediatrics PediNail™ Intramedullary Nailing System primarily relies on substantial equivalence to legally marketed predicate devices. The evidence provided is focused on non-clinical laboratory testing to demonstrate the device's functional equivalence rather than clinical performance (e.g., patient outcomes, diagnostic accuracy).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity, or success rates in a clinical context) with corresponding numerical targets. Instead, the "acceptance criteria" for this type of device, relying on substantial equivalence, are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The reported device performance is primarily based on non-clinical laboratory testing.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance and Evidence
Design Similarity: The device's design (e.g., rod shape, screw holes, insertion method) is comparable to predicate devices.	"OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design..."
Material Equivalence: The materials used are equivalent to those in predicate devices and meet established standards.	"Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard." (This implies equivalence to predicate devices using similar medical-grade stainless steel that also meet relevant ASTM standards). "...similarities in... materials..."
Functional Equivalence: The device performs its intended function (fixation, stability during healing) comparably to predicate devices.	"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." "Function: The system functions to provide immediate stability and temporary fixation during the natural healing process." This functional claim is supported by the non-clinical testing.
Indications for Use Equivalence: The intended uses of the device are substantially the same as those of legally marketed predicate devices.	The document lists comprehensive indications for use (stabilizing femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing, nonunions, malunions, osteotomy correction, simple long bone fractures, comminuted/spiral/oblique/segmental fractures, polytrauma, multiple fractures, reconstruction after tumor resection, grafting, supracondylar fractures, bone lengthening/shortening, fixation of fractures in proximal/distal third of long bones). This broad list implicitly aligns with the indications of the cited predicate devices.
Biocompatibility/Safety Data: The materials and design do not pose new or different safety concerns compared to predicate devices. (Implicit in substantial equivalence)	The use of 316L stainless steel (ASTM-F138 standard) implies biocompatibility and safety consistent with established medical device materials. Non-clinical testing would also cover mechanical safety aspects.

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

Sample Size: The document does not specify a "test set" in the context of clinical data (e.g., patient images or patient outcomes). The evaluation was primarily based on non-clinical laboratory testing. Therefore, the sample size would refer to the number of devices or components tested in the lab, which is not stated.
Data Provenance: Not applicable in the context of clinical data for this submission. The "data" originated from non-clinical laboratory testing conducted by the manufacturer, OrthoPediatrics, Corp. The geographic origin of this laboratory testing is not specified, but the firm is located in Warsaw, Indiana, USA. The testing is inherently prospective as it was conducted specifically to support this submission.

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

Not applicable. This submission relies on non-clinical testing and substantial equivalence, not expert-adjudicated clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of the provided documentation.

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

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for evaluating diagnostic or interpretive aids (e.g., AI systems in radiology), not for an intramedullary nailing system which is a physical implant. The submission is based on substantial equivalence through design and material comparisons, and non-clinical functional testing.

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

Not applicable. This device is a physical implant (intramedullary nail), not an algorithm or an AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of substantial equivalence, is established by the performance characteristics and safety profile of the legally marketed predicate devices for their intended use. The non-clinical laboratory testing aims to demonstrate that the new device meets this established "ground truth" of performance and safety as demonstrated by the predicates.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this 510(k) submission as it is not an AI/machine learning device.

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

Not applicable. There is no concept of a "training set" in this 510(k) submission.

Summary

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K083726 #1/2

MAR 1 1 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 PediNailTM Intramedullary NailingSystem
COMMON NAME:	Intramedullary nail
CLASSIFICATION:	21 CFR 888.3020: Intramedullary fixation rod andaccessories: Class II per 21 CFR §888.3020

DEVICE PRODUCT CODE(S): HSB

SUBSTANTIALLY EQUIVALENT DEVICES:

K040929, Tri-Gen Adolescent TAN, Smith & Nephew

K070843, Adolescent Lateral Entry Nail, Synthes

K983942, Intramedullary Nail System (stainless steel), Smith & Nephew

K993956, Titanium Pediatric Femoral Nail, Biomet

K072161, Femoral Locking Nail System, Biomet

K040336, Lateral Entry Femoral Nail System, Synthes

DEVICE DESCRIPTION:

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K083726 #2/2

impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

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:

The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

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.

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

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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 three overlapping wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthopediatrics, Corp. % Mr. Gary Barnett VP, Regulatory & Medical Affairs 210 North Buffalo Street Warsaw, Indiana 46580

Re: K083726

Trade/Device Name: OrthoPediatrics PediNail™ Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 10, 2008 Received: December 15, 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 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.

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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 Biometric's (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,

Sana Ahmed. for.

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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Indications for Use Statement

510(k) Number (if known): KO 83776

Device Name: OrthoPediatrics PediNail ™ Intramedullary Nailing System

Additional indications include simple long bone fractures; severely comminuted. spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

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

Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	S/m D.
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

s10(k) Number	Page 1
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Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.