(86 days)
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.
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 revasularization. Longer length nails are curved. The holes/slots accept cortical screws for locking of the nail.
The provided text describes a medical device called the "Supracondylar Intramedullary Nail" and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of performance metrics for an AI/ML algorithm.
The document discusses:
- Device Description: A cannulated rod for fixing femur fractures.
- Intended Use: Fixation of supracondylar or distal femur fractures.
- Performance Data: Physical testing (four-point bend testing) of the nail's bending strength and rigidity compared to predicate devices.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in lowercase letters.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
SEP 2 5 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: 219-372-4561 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
Image /page/0/Picture/20 description: The image shows a hexagonal design composed of six identical triangular sections arranged around a central point. Each triangular section contains a smaller triangle within it, creating a pattern of nested triangles. The overall design has a symmetrical and geometric appearance.
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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 revasularization. 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
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.