TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
Device Facts
| Record ID | K962047 |
|---|---|
| Device Name | TITANIUM CANNULATED TIBIAL NAIL (TI CTN) |
| Applicant | Synthes (Usa) |
| Product Code | JDS · Orthopedic |
| Decision Date | Jul 24, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| 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).
Indications for Use
Indicated for patients with open and closed tibial shaft fractures, pre- and post-isthmic fractures, tibial malunions, and tibial non-unions requiring stabilization.
Regulatory Classification
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
Related Devices
- K032097 — DEPUY ACE VERSANAIL TIBIAL NAIL · DePuy Orthopaedics, Inc. · Aug 8, 2003
- K961027 — ORTHOFIX TIBIAL NAILING SYSTEM · Orthofix, Inc. · May 8, 1996
- K970202 — DEPUY ACE AIM TITANIUM TIBIAL NAIL · Depuy Ace Medical Co. · Mar 21, 1997
- K150867 — Affixus Tibial Nailing System · Biomet, Inc. · Jun 10, 2015
- K003018 — TITAN TIBIAL NAIL · Howmedica Osteonics Corp. · Dec 15, 2000
