← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K111444 # UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION (K111444) _DePuy Orthopaedics, Inc. · HSB · Jun 22, 2011 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K111444 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Jun 22, 2011 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Universal and Troch Entry Femoral Nailing Systems Line Extension is 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 Story Intramedullary fixation system for femoral fractures; consists of titanium alloy nails (9-15mm diameter, 280-500mm length) and 5mm distal screws. Used by orthopedic surgeons in clinical/surgical settings for internal fixation of femoral bone fractures. Provides mechanical stabilization of bone segments to facilitate healing. Line extension adds 5mm distal screws (20-80mm) to existing system. Output is physical stabilization of the femur; aids in patient recovery by restoring structural integrity of the bone. ## Clinical Evidence Bench testing only. Dimensional analysis, torque, and bend testing performed on 5mm screws to verify mechanical equivalence to predicate devices. No clinical data presented. ## Technological Characteristics Titanium alloy intramedullary fixation nails and screws. Dimensions: 9-15mm diameter, 280-500mm length; 5mm distal screws (20-80mm). Mechanical fixation principle. No software or energy source. ## Regulatory 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. ## Predicate Devices - Universal and Troch Entry Femoral Nailing Systems ([K033329](/device/K033329.md)) - Hip Fracture Nail ([K100238](/device/K100238.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## દ્વાાવવપ્ . JUN 2 2 2011 ### 510(k) Summary | Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (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 Femoral
Nailing Systems Line Extension Intramedullary fixation rod and
accessories | | | | | | Name of Predicate Devices | The device is substantially equivalent to the currently marketed DePuy
Universal and Troch Entry Femoral Nailing Systems, K033329 and the Hip
Fracture Nail, K100238. | | | | | | Classification | Class II, 21 CFR 888.3020, product code HSB | | | | | | Performance Standards | Performance standards have not been established by the FDA under
section 514 of the Food, Drug and Cosmetic Act for these devices. | | | | | | 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. | | | | | Page 1 of 2 : {1}------------------------------------------------ # KII1444 | Indications for
Use | The Universal and Troch Entry Femoral Nailing Systems Line Extension is
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. | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Technological
Characteristics | The technological characteristics of the Universal and Troch Entry
Femoral Nailing Systems Line Extension are similar to the predicate
devices in both design and material. The systems are manufactured from
titanium alloy. Dimensional characteristics are similar among the systems
and identical to the screws in the Hip Fracture Nail System. | | | Summary of
Substantial
Equivalence | The Universal and Troch Entry Femoral Nailing System Line Extension is
substantially equivalent to the predicate devices as confirmed through
bench testing. Dimensional analysis, torque and bend testing
demonstrated that the 5mm screws performed equivalently to the
predicate devices, successfully meeting the pre-determined acceptance
criteria. | | Page 2 of 2 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ ### 510(k) Number: #### Universal and Troch Entry Femoral Nail Systems Device Name: Line Extension 4111444 #### Indications For Use: 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. 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K111444](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K111444) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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