(32 days)
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K/DEN number: Not Found
No
The device description and intended use clearly describe a mechanical external fixation clamp. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is described as an external fixation clamp intended to provide stabilization of fractures, which falls under the definition of a therapeutic device.
No
The device is described as an external fixation clamp for stabilizing fractures, not for diagnosing conditions.
No
The device description explicitly states it is a physical clamp manufactured from Stainless Steel and Aluminum, intended to connect components of external fixation systems. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "external fixation clamp" used to stabilize fractures. This is a surgical device used directly on the patient's body.
- Device Description: The description details a mechanical clamp made of stainless steel and aluminum, designed to connect components of external fixation systems. This is a physical medical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) as a structural support for fracture healing.
N/A
Intended Use / Indications for Use
This submission describes an external fixation clamp to used to provide a hybrid construct combining the pin fixation of the Monotube® External Fixation System with the Ring and wire fixation of the Monticelli/Spinelli Circular External Fixation This device is intended to provide stabilization of open System. and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
Product codes
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Device Description
The Monotube® Tube to Ring Clamp is designed to connect the Ring of a Monticelli/Spinelli Circular Frame to a Monotube® Tube. The Clamp provides for anqulation between the circular frame and the tube of the external frame system. The Clamp is manufactured from Stainless Steel and Aluminum.
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
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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)
Testing of this device is presented within the submission. Testing was preformed to compare the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame using components of the Hoffmann External Fixation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K961618 MAY 28 1996
510(k) Summary
Prepared : April 19, 1996
| Trade Name: | Monotube® Tube to Ring Clamp | |
|---|---|---|
| Common Name: | External Fixation Clamp | |
| Classification Name: | SMOOTH OR THREADED METALLIC BONE | |
| FIXATION FASTENER 888.3040 |
This submission describes an external fixation clamp to used to provide a hybrid construct combining the pin fixation of the Monotube® External Fixation System with the Ring and wire fixation of the Monticelli/Spinelli Circular External Fixation This device is intended to provide stabilization of open System. and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The Monotube® Tube to Ring Clamp is designed to connect the Ring of a Monticelli/Spinelli Circular Frame to a Monotube® Tube. The Clamp provides for anqulation between the circular frame and the tube of the external frame system. The Clamp is manufactured from Stainless Steel and Aluminum.
Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling), the Synthes Ring-to-Rod Clamp and the Zimmer Torus Ring-to-Rod Clamp.
Testing of this device is presented within the submission. Testing was preformed to compare the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame using components of the Hoffmann External Fixation System.
For information contact: John Dichiara Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870