SUPRACONDYLAR INTRAMEDULLARY NAIL

K962561 · Zimmer, Inc. · HSB · Sep 25, 1996 · Orthopedic

Device Facts

• Record ID: K962561
• Device Name: SUPRACONDYLAR INTRAMEDULLARY NAIL
• Applicant: Zimmer, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Sep 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.

Device Story

Cannulated metallic rod; inserted through condylar notch for fixation of distal femoral fractures. Features: 9-13 mm diameters; varying lengths; fluted design for revascularization; curved profile for longer lengths; multiple proximal/distal holes/slots for locking screws. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of bone fractures; facilitates healing via rigid fixation. Output: physical bone stabilization. Benefit: fracture reduction and stabilization.

Clinical Evidence

Bench testing only. Four-point bend testing performed to evaluate bending strength and rigidity across all nail diameters and designs. Results compared to predicate devices, demonstrating superior strength capabilities.

Technological Characteristics

Cannulated metallic bone fixation fastener. Features fluted design for revascularization. Available in 9-13 mm diameters. Includes proximal and distal holes/slots for cortical screw locking. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with supracondylar or distal femoral fractures, including cases with associated proximal fractures requiring fixation.

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

• Intramedullary Supracondylar Nail (Smith & Nephew Richards, Inc.)
• AIM Supracondylar Nail (Ace Orthopedic Manufacturing Company)

Submission Summary (Full Text)

{0}

PO. Box 708
Warsaw, IN 46581-0708
219 267-6131

# SEP 25 1996

## Summary of Safety and Effectiveness
### Supracondylar Intramedullary Nail

- **Submitted by**
Zimmer, Inc.
P.O. Box 708
Warsaw, Indiana 46581-0708

- **Prepared by**
Lynnette Whitaker
Manager
Regulatory Affairs
Telephone: [phone]
Telefax: 219-372-4605

- **Date**
June 28, 1996

- **Trade Name**
Supracondylar Intramedullary Nail

- **Common Name**
Intramedullary Rod

- **Classification Name**
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener

1
73
A Bristol-Myers Squibb Company

{1}

- Predicate Devices

- Intramedullary Supracondylar Nail, marketed by Smith & Nephew Richards, Inc.

- AIM Supracondylar Nail, marketed by Ace Orthopedic Manufacturing Company

- Device Description

The Supracondylar Nail is a cannulated rod designed to be inserted through the condylar notch in order to fix fractures of the femur. The nail is available in 9 through 13 mm diameters with varying lengths. Each nail contains multiple distal and proximal holes/slots for insertion of locking screws with a cone-shaped head for ease of insertion. The nail is fluted for revascularization. Longer length nails are curved. The holes/slots accept cortical screws for locking of the nail.

- Intended Use

The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.

- Performance Data

The Supracondylar Nail was tested in four-point bend testing for bending strength and bending rigidity. Results showed significant bending strength and bending rigidity for all nail diameters and designs. Slotted nails demonstrated a reduction in bending strength and bending rigidity. The Supracondylar Nail testing results were compared to predicate devices in terms of design and material, indicating superior strength capabilities for the Zimmer Supracondylar Nail.

RA06602K.510

74