(42 days)
Not Found
No
The summary describes a physical implantable device for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for internal fixation of fractures and reconstruction of humeral bone, which are therapeutic interventions.
No
The device is described as an internal wire fixation device used for "internal fixation of fractures and/or reconstruction of the humeral bone". This indicates it is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is an "internal wire fixation device," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Humerus Wires device is an implantable device used for internal fixation of fractures within the body.
The description clearly states its purpose is to be "implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone." This is a surgical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.
Product codes
Not Found
Device Description
The Humerus Wires device is an internal wire fixation device to be used in the fixation of humeral fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K902264, K913949, K811002, K905341, K903261
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 Ferguson Medical. The logo consists of a stylized letter "F" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.
916-342-4133 FAX: 916-343-
DEC - 5 1996
20 September 1996
510(k) SUMMARY
The 510(k) summary information required by CFR 807.92 is as follows :
- A . Classification name: Pin, fixation, smooth
Common/usual name: Fixation wire, fixation pin, nail, rod, and others
Proprietary name: Humerus Wires
- B. Substantial equivalence: Applied Osteo Systems System the Humerus, True/Flex IM Rod for Radius, and Ulna (K902264, K913949), Richards Ender Pins (K811002), O'Tec Corporation and ( K905341 Rush Corporation Pins and Onyx K903261, respectively), and others.
- The Humerus Wires device is C. Device description: an internal wire fixation device to be used in the fixation of humeral fractures.
- D. The Humerus Intended use: Wires device is intended to be implanted in the humerus for and/or internal fixation of fractures reconstruction of the humeral bone.
- E. Technological characteristics: The Humerus Wires
3407 Bay Avenue · Chico, California 95973 · USA
1
device is similar to predicate devices in its design, function, and intended use.
The device is similar to certain predicates which do not utilize a locking screw, but it is unlike predicates which do utilize such a locking component.
The Humerus Wires device is manufactured from materials presently and/or previously utilized in FDA-cleared medical devices.
Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794
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Frank Ferguson Official Correspondent