(70 days)
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No
The device description and performance studies focus on the mechanical properties and design of the intramedullary nail system, with no mention of AI or ML capabilities.
Yes
The device is described as an Intramedullary Nail System used for the fixation of long bone fractures, which is a therapeutic intervention.
No
The device description and intended use indicate that the Intramedullary Nail System is a surgical implant used for the fixation of bone fractures, not for diagnosing conditions.
No
The device description clearly states it is a "series of cannulated intramedullary rods and interlocking screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures in the femur, tibia, and humerus. This is a surgical intervention on the human body.
- Device Description: The description details a system of intramedullary rods and screws, which are physical implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / 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
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Long bone, femoral, tibial, humeral
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kuntscher Nail, Russell-Taylor Intramedullary Nail, Supracondylar Nail, manufactured by Zimmer, Inc., K962561
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The letter "Z" is bold and black, and the circle is a thin black line. The word "zimmer" is also black and in a sans-serif font.
(
FEB 2 8 1997
P.O. 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 ﮯ Richards, Inc.
Image /page/0/Picture/21 description: The image contains a number. The number is 318. The number is written in a bold, sans-serif font. The number is black.
Image /page/0/Picture/22 description: The image shows a black and white geometric design. The design is a hexagon with a complex pattern inside. The pattern consists of triangles and lines that create a star-like shape in the center. The overall design is symmetrical and intricate.
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
2