← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K032722 # TRIGEN STRAIGHT HUMERAL NAIL SYSTEM (K032722) _Smith & Nephew, Inc. · HSB · Oct 1, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032722 ## Device Facts - **Applicant:** Smith & Nephew, Inc. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Oct 1, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only. ## Device Story Intramedullary nail system for surgical fixation of humeral fractures. Device implanted by orthopedic surgeons in clinical/OR settings to stabilize bone segments. Provides mechanical support to withstand in vivo loading. Single-use device. ## Clinical Evidence Bench testing only. Mechanical test data indicates the system is equivalent to devices currently used clinically and capable of withstanding expected in vivo loading. ## Technological Characteristics Intramedullary fixation rod (21 CFR 888.3020). Design features and material composition are consistent with predicate intramedullary nail systems. ## 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 - Smith & Nephew's Titanium Nail System ([K981529](/device/K981529.md)) - Smith & Nephew's Intramedullary Nail System ([K983942](/device/K983942.md)) - Acumed's Polarus nails ([K951740](/device/K951740.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}------------------------------------------------ OCT - 1 2003 Ko327da page 1 of 1 # Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Straight Humeral Nail System ## Contact Person and Address Date of Summary: September 2, 2003 Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153 Name of Device: TriGen Straight Humeral Nail System Common Name: Intramedullary Nail ## Device Classification Name 21 CFR 888.3020 Intramedullary Fixation Rod - Class II ### Indications for Use The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only. #### Mechanical and Clinical Data A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure. #### Substantial Equivalence Information The substantial equivalence of the TriGen Straight Humeral Nail System 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), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K951740). {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT = 1 2003 Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116 Re: K032722 Trade/Device Name: TriGen Straight Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Inrtramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2003 Received: September 4, 2003 Dear Ms. Akil: 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. {2}------------------------------------------------ ## Page 2 - Ms. Janet Johnson Akil 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 Manufacturers, 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, 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}------------------------------------------------ K03a7a2 # TriGen Straight Humeral Nail System Indications Statement The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only. Marli N. Mellema Restorative and Neuro 510(k) Number - Concurrence of CDRH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032722](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K032722) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com