← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K043404 # MODIFICATION TO T2 PROXIMAL HUMERAL NAIL (K043404) _Howmedica Osteonics Corp. · HSB · Dec 27, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K043404 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Dec 27, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification. ## Device Story T2 Proximal Humeral Nail is an intramedullary fixation device for temporary stabilization of humeral fractures. Device is inserted via open or closed surgical technique; allows for static or dynamic locking. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical stability to bone segments to facilitate healing. Benefits include fracture stabilization and management of pathological bone conditions. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence established via FEA analysis and mechanical testing. ## Technological Characteristics Intramedullary fixation rod. Material composition identical to predicate. Designed for single use. Static or dynamic locking capability. ## 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. ## 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}------------------------------------------------ K043404 #### Special 510(k) # DEC 27 2004 # 510(k) Summary of Safety and Effectiveness: T2 PHN Line Extension ## Submission Information Name and Address of the Sponsor of the 510(k) Submission: For Information contact: Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038 Date Summary Prepared: December 10, 2004 ### Device Identification Proprietary Name: Common Name: Classification Name and Reference: Device Product Code: T2 Proximal Humeral Nail Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR \$888.3020 87 HSB #### Description: This Special 510(k) submission is a line extension to the T2 Nailing System to add a new style of Proximal Humeral Nail. The nails are inserted using an opened or closed technique and can be statically or dynamically locked. The T2 Proximal Humeral Nail is intended for single use only. ### Intended Use: The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification. ## Statement of Technological Comparison: The material used to manufacture the line extension to the T2 Nail System is identical to that of the predicate. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject T2 Nail System to the predicate device. {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 27 2004 Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430 Re: K043404 Trade/Device Name: T2 Proximal Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 10, 2004 Received: December 10, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Vivian 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 (240) 276-0120. 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. R. Mark N. Millherson 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}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: T2 Proximal Humeral Nail Indications for Use: The T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of The TE = = = limited to, non-unions, malunions, malalignments, pathological fractures, and impending minological fractures. Examples of specific indications according to AO classification include Paired B Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark H. Mulhern Page 1 of 1 Division of General, Restorative, and Neurological Devices 510(k) Number K043404 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K043404](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K043404) **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