(149 days)
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No
The summary describes a mechanical fracture fixation system with plates, screws, and staples. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
This device is for fracture fixation and stabilization during the healing process, not for directly treating a disease or therapeutic condition.
No
The device is a fracture fixation system used for surgical procedures like osteotomies, providing stability and fixation during the healing process, not diagnosing medical conditions.
No
The device description explicitly states it consists of physical components made of metal (L-plates, screws, staples) and is used for fracture fixation, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Metagen High Tibial Osteotomy System is a surgical implant used for the fixation of bones during and after surgical procedures. It is a physical device that is placed inside the body to provide structural support.
- Intended Use: The intended use clearly states it's for "fixation of fractures" and "stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone." This is a mechanical function, not a diagnostic test performed on a sample.
The description of the device, its materials, and its function all point to it being a surgical implant for orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.
Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.
Product codes
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Device Description
The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples.
Materials: The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6A1-V, and 316 LVM stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.
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
proximal or distal end of long bones
Indicated Patient Age Range
young, active patients
Intended User / Care Setting
Not Found
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
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Key Metrics
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Predicate Device(s)
NexGen Osteotomy System ( Zimmer ), Natural Knee Family High Tibial Osteotomy System ( Intermedics Orthopedics ), High Tibial Osteotomy System ( Richards ), L-buttress, T-buttress and T-plates ( Synthes ), ECT Internal Fracture Fixation System ( Zimmer ), Improved Geibel Blade Plates ( Link America Inc. ), Osteo Auto-Compression Plating System ( Smith & Nephew Richards ), May Anatomical Bone Plates ( Waldemar Link )
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
FEB 1 2 1997
for
Metagen High Tibial Osteotomy System
This safety and effectiveness summary for the Metagen High Tibial Osteolomy System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter : | Contact Person : |
|---|---|
| Metagen, LLC | Wesley Johnson |
| Origen Center | Metagen, LLC |
| 428 Technology Drive East | Origen Center |
| Menomonie, Wisconsin 54751 | 428 Technology Drive East |
| Menomonie, Wisconsin 54751 | |
| Telephone: (715) 232-4880 |
Date Prepared: September 9,1996
| 2. Trade Name: | Metagen High Tibial Osteotomy System |
|---|---|
| Common Name: | Fracture Fixation System |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories (888.3030) |
3. Predicate or legally marketed devices which are substantially equivalent:
- . NexGen Osteotomy System ( Zimmer )
- Natural Knee Family High Tibial Osteotomy System ( Intermedics Orthopedics ) .
- High Tibial Osteotomy System ( Richards ) .
- . L-buttress, T-buttress and T-plates ( Synthes )
- . ECT Internal Fracture Fixation System ( Zimmer )
- Improved Geibel Blade Plates ( Link America Inc. ) .
- Osteo Auto-Compression Plating System ( Smith & Nephew Richards ) .
- May Anatomical Bone Plates ( Waldemar Link ) .
4. Description of the device :
The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples.
Materials: The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6A1-V, and 316 LVM stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.
5. Intended Use:
The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.
Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Metagen High Tibial Osteotomy System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.