← Product Code [HSB](/submissions/OR/subpart-d-prosthetic-devices/HSB) · K955761 # TIBIA ORTHONAIL (K955761) _Orthologic Corp. · HSB · Mar 13, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d-prosthetic-devices/HSB/K955761 ## Device Facts - **Applicant:** Orthologic Corp. - **Product Code:** [HSB](/submissions/OR/subpart-d-prosthetic-devices/HSB.md) - **Decision Date:** Mar 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Tibia OrthoNail is indicated for stabilizing tibial fractures. ## Device Story Tibia OrthoNail; intramedullary fixation device; solid titanium alloy cylinder; used for stabilizing tibial fractures; implanted by orthopedic surgeons in clinical/OR settings; device accepts transfixing screws; includes impacting anvil and alignment tower for surgical insertion/distraction; provides mechanical stabilization of bone fragments to facilitate healing. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Material: Titanium alloy 6Al-4V (ASTM F 136-92). Form factor: Solid cylinder, 9-14 mm diameter, 200-425 mm length. Features: Transfixation screw holes, end caps. Accessories: Impacting anvil, alignment tower. Energy source: None (mechanical). ## 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 - Applied Osteo Systems True/Flex - Richards Russell-Taylor ## Related Devices - [K170972](/device/K170972.md) — Apex Tibial Nailing System · Orthoxel · Dec 20, 2017 - [K961027](/device/K961027.md) — ORTHOFIX TIBIAL NAILING SYSTEM · Orthofix, Inc. · May 8, 1996 - [K972183](/device/K972183.md) — DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL · Ace Medical Co. · Aug 26, 1997 - [K970202](/device/K970202.md) — DEPUY ACE AIM TITANIUM TIBIAL NAIL · Depuy Ace Medical Co. · Mar 21, 1997 - [K003018](/device/K003018.md) — TITAN TIBIAL NAIL · Howmedica Osteonics Corp. · Dec 15, 2000 ## Submission Summary (Full Text) {0} MAR 13 1996 OrthoLogic Corp. Premarket Submission K955701 OrthoNail 510(k) 510(k) SUMMARY Tibia OrthoNail December 15, 1995 K955701 This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87. 1. **Submitter of 510(k)** Company Name: OrthoLogic Corp Address: 2850 South 36th Street Phoenix, Arizona 85034 Contact Person: James Koeneman, Ph.D., Vice President of Engineering Telephone: (602) 437-5520 Fax: (602) 437-5524 2. **Name of Device:** **Trade/Proprietary Name:** Tibia OrthoNail **Common/Usual Name:** Intramedullary Fixation Device **Classification Name:** 21 CFR 888.3020 “Intramedullary Fixation Rod”, Class II. 3. **Legally Market Predicate Devices** The Tibia OrthoNail is substantially equivalent to many legally marketed intramedullary fixation devices including those listed Table 1 below. 4. **Device Description** The Tibia OrthoNail is indicated for stabilizing tibial fractures. All implanted components are manufactured from titanium alloy, 6Al-4V, conforming to ASTM F 136-92. The components include IM Nails, end caps, and instrumentation. CONFIDENTIAL Appendix 5, Page 2 of 3 {1} OrthoLogic Corp. Premarket Submission OrthoNail 510(k) The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction. Table 1 Comparison of Technological Characteristics Predicate Devices and the Tibia OrthoNail | Manufacturer | OrthoLogic | Applied Osteo Systems | Richards | | --- | --- | --- | --- | | Device | OrthoNail | True/Flex | Russell-Taylor | | Technologic Characteristic | | | | | Tibial | yes | yes | yes | | Solid Section | Yes | Yes | Yes | | Transfixation Holes | Yes | Yes | Yes | | Material | Titanium Alloy | Titanium Alloy | Stainless Steel | | Diameter | 9 - 14mm | 9, 10 mm | 11-14 mm | | Length | 200 - 425 mm | 285 - 390mm | 285 - 380 mm | Based on the information provided, the Tibia OrthoNail is substantially equivalent to legally marketed predicate devices. CONFIDENTIAL Appendix 5, Page 3 of 3 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d-prosthetic-devices/HSB/K955761](https://fda.innolitics.com/submissions/OR/subpart-d-prosthetic-devices/HSB/K955761) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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