(35 days)
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No
The summary describes a mechanical device used with an external fixation system and makes no mention of AI or ML technology.
Yes
The device is used to treat joint contractures and restore mobility and function of a joint, which are therapeutic actions.
No
The device is described as a treatment device used for joint contractures and to restore mobility and function. It does not mention diagnosing conditions.
No
The device description clearly states it is a "device used with external fixation devices" and is "applied to bones on both sides of a joint," indicating it is a physical hardware component, not software.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Compass Universal Hinge is a mechanical device used externally to treat joint contractures and restore range of motion. It is applied to bones and facilitates physical movement of the joint.
- Lack of Biological Sample Testing: The description clearly states its use in conjunction with an external fixation system for physical manipulation of a joint. There is no mention of testing biological samples.
Therefore, based on the provided information, the Compass Universal Hinge falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Compass Universal Hinge is a device used with external fixation devices for the indications listed previously. The Compass Universal Hinge is applied to bones on both sides of a joint to provide active and passive motion of the joint and to restore loss of range of motion due to contracture.
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
bones on both sides of a joint
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)
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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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
APR - 3 1997
Summary of Safety and Effectiveness Compass Universal Hinge
Substantial Equivalence Information
The Compass Universal Hinge is similar to Smith & Nephew's Ilizarov External Fixator and Howmedica's Dynamic Joint Distractor. All of these devices use external fixation to treat joint contracture or fractures and diseases that may lead to joint contracture. The Compass Universal Hinge represents improvements that enhance user convenience.
Device Description
The Compass Universal Hinge is a device used with external fixation devices for the indications listed previously. The Compass Universal Hinge is applied to bones on both sides of a joint to provide active and passive motion of the joint and to restore loss of range of motion due to contracture.
Indications for Use
The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.