(59 days)
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No
The 510(k) summary describes a purely mechanical bone screw with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a bone screw intended for fracture and osteotomy fixation, which are therapeutic medical interventions.
No
The device is a bone screw, which is an implant used for fixation, not for diagnosing conditions.
No
The device description clearly states it is a physical bone screw made of titanium alloy, which is a hardware component.
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) to provide information for diagnosis, monitoring, or screening.
- The description of the 2.7mm Extremity Bone Screw clearly states its intended use is for "fracture and osteotomy fixation of the upper and lower extremities." This is a surgical implant used directly on the body for structural support and repair.
The information provided about the device's material, dimensions, sterilization, and testing all relate to its function as a surgical implant, not as a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc.
Product codes
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Device Description
The 2.7mm Extremity Bone Screw is available in lengths of 12mm. 14mm. 16mm, 18mm, 20mm, 22mm, and 24mm. The screw is driven by a conventional 2.5mm hex head. Hex dimensions are in accordance with ASTM F 543. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided non-sterile. On file at Acumed is test data which shows that the screw can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 106. As the screw is provided non-sterile, packaging information is not provided.
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
upper and lower extremities
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
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Key Metrics
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Predicate Device(s)
Synthes' 3mm Cannulated Screw System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
TO
Image /page/0/Picture/3 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are all capitalized and have a slightly futuristic or technical appearance. There is a horizontal line underlining the entire word, and the letters "TM" are in superscript to the right of the word.
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
OCT 10 1996
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The 2.7mm Extremity Bone Screw is intended for fracture and osteotomy fixation of the upper and lower extremities. This screw is not intended for usage in the spine and is not for use with any available bone plates, washers, etc. This screw is available in lengths of 12mm. 14mm. 16mm, 18mm, 20mm, 22mm, and 24mm. The screw is driven by a conventional 2.5mm hex head. Hex dimensions are in accordance with ASTM F 543. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided non-sterile. On file at Acumed is test data which shows that the screw can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 106. As the screw is provided non-sterile, packaging information is not provided.
The 2.7mm Extremity Bone Screw is similar to Synthes' 3mm Cannulated Screw System in design, function, indications, and surgical technique and is expected to perform as well as similar devices.
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