CANNULATED FEMORAL NAIL

K954856 · Synthes (Usa) · JDN · Mar 8, 1996 · Orthopedic

Device Facts

• Record ID: K954856
• Device Name: CANNULATED FEMORAL NAIL
• Applicant: Synthes (Usa)
• Product Code: JDN · Orthopedic
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.

Device Story

Cannulated locking intramedullary fixation device; titanium alloy construction; facilitates insertion over guide rod into reamed/unreamed femur; gradual anterior bow approximates femoral curvature; proximal/distal locking holes use 4.9 mm bolts; proximal hole elongated; accessories include twisted blade, 5.0 mm shaft screws, locking sleeves, end caps; used by surgeons in clinical/OR settings to stabilize femoral fractures; accessories transmit load to prevent rotation/displacement; benefits include fracture stabilization and support for non-unions.

Clinical Evidence

Bench testing only; mechanical test results demonstrate CFN design is at least equivalent to URFN predicate.

Technological Characteristics

Titanium alloy; cannulated intramedullary nail; anterior bow; proximal/distal locking holes; 4.9 mm locking bolts; accessories include twisted blade, 5.0 mm shaft screws, locking sleeves, end caps; moist heat sterilization per AAMI guidelines.

Indications for Use

Indicated for patients with acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Synthes Unreamed Femoral Nail (URFN)

Submission Summary (Full Text)

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SYNTHES

454854

8

# Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]

Synthes (USA)
1690 Russell Road
Paoli, PA 19301

[phone]
Contact: Angela Silvestri
October 20, 1995

Device: Synthes Cannulated Femoral Nail (CFN) System is compared to Synthes Unreamed Femoral Nail (URFN).

Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures. Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insertion over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.

Synthes URFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, and impending pathological fractures. The Synthes URFN is also intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures and post-isthmic femoral fractures. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The proximal-most locking hole is elongated. It has a solid cross section to facilitate insertion into a non-reamed or minimally reamed femur. The device is manufactured from titanium alloy.

Synthes will provide the device both sterile and non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance".

Based on mechanical test results, the CFN design has been found to be at least equivalent to the URFN.