Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric / intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trohchanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.

Device Description

The Universal and Troch Entry Femoral Nailing Systems Line Extension offers an additional 5mm distal screw, 20-80mm. The system consists of Universal and Troch Entry nails for femoral fracture fixation. The titanium nails range in diameter from 9 - 15mm and lengths of 280 - 500mm.

AI/ML Overview

This document describes the 510(k) summary for the DePuy Orthopaedics, Inc. Universal and Troch Entry Femoral Nailing Systems Line Extension. The device is an intramedullary fixation rod and accessories intended to treat various femoral fractures and conditions.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Bench Testing)	Reported Device Performance (Bench Testing)
5mm screws perform equivalently to predicate devices	Successfully met pre-determined acceptance criteria
Dimensional analysis similar to predicate devices	Similar to predicate devices
Torque testing similar to predicate devices	Performed equivalently to predicate devices
Bend testing similar to predicate devices	Performed equivalently to predicate devices

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

The document explicitly states "bench testing" was performed to confirm substantial equivalence. No information is provided regarding human test subjects or clinical data, thus no sample size for a "test set" in the context of clinical studies, nor data provenance (e.g., country of origin, retrospective/prospective), is applicable or provided.

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

This information is not applicable. The study involved bench testing of the device's physical and mechanical properties, not an evaluation of clinical performance requiring expert ground truth in a medical context.

4. Adjudication Method for the Test Set:

This information is not applicable, as the study involves bench testing of mechanical properties, not human judgment or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The study presented here is a 510(k) submission focused on demonstrating substantial equivalence through bench testing, not a clinical effectiveness study.

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

This concept is not applicable to the device described. This device is a medical implant (intramedullary fixation rod), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation was based on engineering and material science principles, specifically the established performance characteristics and dimensional profiles of already marketed predicate devices. The new 5mm screws were compared against these known, accepted standards.

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical medical device, not an AI or algorithm that requires a "training set" in the computational sense.

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

This information is not applicable for the reasons stated above.

Summary

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દ્વાાવવપ્

JUN 2 2 2011

510(k) Summary

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441
Contact Person:	Suzana Otaño, Project Manager, Regulatory Affairs
Date Prepared:	May 17, 2011
General Provisions	The name of the device is:
	Proprietary Name Common or Usual Name Universal and Troch Entry FemoralNailing Systems Line Extension Intramedullary fixation rod andaccessories
Name of Predicate Devices	The device is substantially equivalent to the currently marketed DePuyUniversal and Troch Entry Femoral Nailing Systems, K033329 and the HipFracture Nail, K100238.
Classification	Class II, 21 CFR 888.3020, product code HSB
Performance Standards	Performance standards have not been established by the FDA undersection 514 of the Food, Drug and Cosmetic Act for these devices.
Device Description	The Universal and Troch Entry Femoral Nailing Systems Line Extensionoffers an additional 5mm distal screw, 20-80mm. The system consists ofUniversal and Troch Entry nails for femoral fracture fixation. The titaniumnails range in diameter from 9 - 15mm and lengths of 280 - 500mm.

Page 1 of 2

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KII1444

Indications forUse	The Universal and Troch Entry Femoral Nailing Systems Line Extension isintended to treat proximal, middle and distal third fractures, severelycomminuted shaft fractures extending beyond the isthmus, spiral, longoblique and segmental fractures, non-unions and malunions, lengtheningof the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosisof the femoral shaft, supracondylar fractures, subtrochanteric fractures,with or without involvement of lesser trochanter, subtrochanteric /intertrochanteric combination fractures, ipsilateral femoral shaft and neckfractures, stable and unstable proximal fractures of the femur, includingpertrochanteric fractures, intertrochanteric fractures, high subtrochantericfractures and combinations of these fractures, pertrochanteric featuresassociated with shaft fractures, pathologic fractures in osteoporotic boneof the trohchanteric and diaphyseal areas, proximal or distal non-unionsand malunions, leg length discrepancies secondary to femoral inequality,femur reconstruction following tumor resection, stable femoral fractureswithout necessity for interlocking, long subtrochanteric fractures, andrevision procedures involving the replacement of implanted hardware.In addition to the above indications, the Universal NAIL, when used in theretrograde mode, is also indicated for treatment of femoral shaft fracturesin obese or multiple trauma patients and supracondylar fractures,including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologicfractures, and those proximal to total knee prosthesis.
TechnologicalCharacteristics	The technological characteristics of the Universal and Troch EntryFemoral Nailing Systems Line Extension are similar to the predicatedevices in both design and material. The systems are manufactured fromtitanium alloy. Dimensional characteristics are similar among the systemsand identical to the screws in the Hip Fracture Nail System.
Summary ofSubstantialEquivalence	The Universal and Troch Entry Femoral Nailing System Line Extension issubstantially equivalent to the predicate devices as confirmed throughbench testing. Dimensional analysis, torque and bend testingdemonstrated that the 5mm screws performed equivalently to thepredicate devices, successfully meeting the pre-determined acceptancecriteria.

Page 2 of 2

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a stylized head.

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

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthoaedic Drive Warsaw, IN 46581

JUN 2 2 2011

Re: K111444

Trade/Device Name: Universal and Troch Entry Femoral Nail Systems Line Extension Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 17, 2011 Received: May 24, 2011

Dear Ms. Otaño:

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

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Page 2 - Ms. Suzana Otaño

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

DEP CLIM

Mark N. Melkerson
Director
Division of Surgical, Orthopedic,
and Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Universal and Troch Entry Femoral Nail Systems Device Name: Line Extension

4111444

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (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)

for M, Melkersm Page 1 of 1
(Divisibr Sign Oft)

(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111444

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.