← Product Code [JDS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS) · K962047 # TITANIUM CANNULATED TIBIAL NAIL (TI CTN) (K962047) _Synthes (Usa) · JDS · Jul 24, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K962047 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JDS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS.md) - **Decision Date:** Jul 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions. ## Device Story Titanium cannulated tibial nail; used for stabilization of tibial fractures. Features cannulated tube with sagittal plane bend for insertion; four proximal and three distal locking holes for 4.9 mm titanium locking bolts. Available in 11-14 mm diameters; 255-420 mm lengths. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical fixation to stabilize bone segments; facilitates healing of fractures, malunions, and non-unions. ## Clinical Evidence Bench testing only. ## Technological Characteristics Material: Titanium. Design: Cannulated tube with sagittal plane bend. Dimensions: 11-14 mm diameter; 255-420 mm length. Locking mechanism: 4.9 mm titanium locking bolts. Sterilization: Steam (Pre-Vacuum: 132°C-135°C for 6 min; Gravity Displacement: 132°C-135°C for 15 min). ## 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 - Synthes Ti-6Al-7Nb Unreamed Tibial Nail ## Reference Devices - Synthes Titanium Tibial Nail System ## 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} SYNTHES K962047 Attachment VII: Summary of Safety and Effectiveness Information Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri May 1996 JUL 24 1996 Synthes Titanium Cannulated Tibial Nail (Ti CTN) is compared to Synthes Ti-6Al-7Nb Unreamed Tibial Nail and is an extension to Synthes Titanium Tibial Nail System. Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions. The Synthes Ti CTN is available in sizes ranging from 11 mm to 14 mm in diameter and in lengths ranging from 255 mm to 420 mm. The nail has a cannulated tube with a bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts. The devices will be provided both sterile and non-sterile. The non-sterile devices must be sterilized prior to use. The following sterilization parameters are recommended: | Method | Cycle | Time | Temperature | | --- | --- | --- | --- | | Steam | Pre-Vacuum | 6 minutes | 132°C - 135°C | | Steam | Gravity Displacement | 15 minutes | 132°C - 135°C | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K962047](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDS/K962047) **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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