K965098 · Zimmer, Inc. · HSB · Feb 28, 1997 · Orthopedic
Device Facts
Record ID
K965098
Device Name
INTRAMEDULLARY NAIL SYSTEM
Applicant
Zimmer, Inc.
Product Code
HSB · Orthopedic
Decision Date
Feb 28, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3020
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions. The humeral Nail is indicated for comminuted fractures, segmental fractures, fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries
Device Story
Intramedullary Nail System consists of cannulated rods and interlocking screws for long bone fracture fixation; femoral, tibial, and humeral variants. Design features: four longitudinal flutes; larger nails include sawcut for insertion; conical, tapered distal tip; proximal/distal holes for interlocking screws. Used in locked or unlocked mode; inserted via closed technique with or without medullary canal reaming. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of fractures; aids bone healing; benefits patients by restoring structural integrity to fractured long bones.
Clinical Evidence
Bench testing only. Bending strength/stiffness and static torsional strength evaluated per ASTM F 383. Results demonstrate significant strength comparable to predicate devices.
Technological Characteristics
Materials: stainless steel. Design: cannulated intramedullary rods with four longitudinal flutes, conical tapered distal tip, and interlocking screw holes. Testing standard: ASTM F 383 (static bend and torsion).
Indications for Use
Indicated for patients with femoral, tibial, or humeral fractures, including comminuted, segmental, subtrochanteric, intertrochanteric, proximal/distal fractures, nonunions, delayed unions, pathological fractures, floating elbow, nerve lesions, and multiple trauma injuries.
Regulatory Classification
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
Kuntscher Nail (Zimmer, Inc.)
Russell-Taylor Intramedullary Nail (Smith and Nephew Richards, Inc.)
{0}
PO. Box 708
Warsaw, IN 46581-0708
219 267-6131
# Summary of Safety and Effectiveness
- **Submitted By**
Zimmer, Inc.
P.O. Box 708
Warsaw, Indiana 46581-0708
219-267-6131
- **Contact Person**
Karen Cain
Regulatory Affairs Specialist
Telephone: 219-372-4219
Fax: 219-372-4605
- **Date**
December 12, 1996
- **Trade Name**
Intramedullary Nail System
- **Common Name**
Intramedullary Rod
- **Classification Name**
Intramedullary Fixation Rod
- **Predicate Devices**
- Kuntscher Nail, manufactured by Zimmer, Inc.
- Russell-Taylor Intramedullary Nail, manufactured by Smith and Nephew Richards, Inc.
318
A Bristol-Myers Squibb Company
{1}
- Supracondylar Nail, manufactured by Zimmer, Inc., K962561, cleared September 25, 1996
- **Device Description**
The Intramedullary Nail System is a series of cannulated intramedullary rods and interlocking screws for use in fixation of long bone fractures. Included in the system are femoral, tibial and humeral nails in varying diameters and lengths. The design of the nail includes four longitudinal flutes along the length of the nail. The larger sized nails have a sawcut over the majority of the length of the nail to aid in insertion. The distal tip of the nail is conical in shape and tapered. All nails include proximal and distal holes for the insertion of interlocking screws. The nails can be used in either the locked or unlocked mode and can be inserted with or without prior reaming of the medullary canal. The nails and screws are manufactured from stainless steel. The nails are inserted using a closed technique.
- **Intended Use**
The intended use of the Intramedullary Nail System is as follows:
### Femoral and Tibial Nails
The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions.
### Humeral Nail
The humeral Nail is indicated for comminuted fractures, segmental fractures, fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries
- **Performance Data**
The Intramedullary Nail System design was tested for bending strength/stiffness and static torsional strength using the ASTM Standard F 383, “Standard Practice for Static Bend and Torsion Testing of Intramedullary Rods.” The results showed significant bending strength for all nail diameters. On a size-per-size basis, the Intramedullary System nails are comparable in strength to the predicate device.
RA12602K.510
