← Product Code [JDS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS) · K040212 # TRIGEN INTERTAN (K040212) _Smith & Nephew, Inc. · JDS · Feb 20, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K040212 ## Device Facts - **Applicant:** Smith & Nephew, Inc. - **Product Code:** [JDS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS.md) - **Decision Date:** Feb 20, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only. ## Device Story TriGen InterTAN is an intramedullary nail system for bone fixation. Device provides mechanical stability for various femoral and long bone fractures. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments during healing. Operates as a metallic implant; provides structural support to withstand in vivo loading. Benefits patients by facilitating bone alignment and stabilization for fracture repair. ## Clinical Evidence Bench testing only; no clinical data provided. Mechanical test data indicates the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading without failure. ## Technological Characteristics Metallic bone fixation appliance; intramedullary nail design. Material composition and design features are substantially equivalent to predicate intramedullary nail systems. ## Regulatory 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. ## Predicate Devices - Smith & Nephew's Titanium Nail System ([K981529](/device/K981529.md)) - Generic Trauma Internal Fixation System ([K993289](/device/K993289.md)) - Intramedullary Nail System ([K983942](/device/K983942.md)) - Stryker Howmedica Trochanteric Dyax Nail System ([K013524](/device/K013524.md)) - DePuy Trochanteric Nail ([K010780](/device/K010780.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}------------------------------------------------ K040212 FEB 2, 0 2004 # Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen InterTAN #### Contact Person and Address Date of Summary: January 29, 2004 Kim Kelly Project Manager, Regulatory/Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566 Name of Device: TriGen InterTAN Common Name: Intramedullary Nail and Accessories #### Device Classification Name 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II #### Indications for Use InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only. ### Mechanical and Clinical Data A review of the mechanical test data indicated that the TriGen InterTAN nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivoloading without failure. ## Substantial Equivalence Information The substantial equivalence of the TriGen InterTAN nail is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Titanium Nail System (K981529), Generic Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942),the Stryker Howmedica Trochanteric Dyax Nail System (K013524), and the DePuy Trochanteric Nail (K010780). {1}------------------------------------------------ Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 0 2004 Ms. Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 Re: K040212 Trade/Device Name: TriGen InterTAN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: January 29, 2004 Received: January 30, 2004 Dear Ms. Kelly: 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Kim Kelly 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, / Mark N. Millbern Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Hoala # TriGen InterTAN Indications Statement InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only. L. Merle N. Milkesen Division Division of General, Restorative, and Neurological Devices 040212 510(k) Number Concurrence of CDRH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _ OR --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K040212](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K040212) **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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