(37 days)
K/DEN number is not provided in the text.
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics related to algorithms indicate it is a traditional mechanical device.
Yes
The device functions as internal fixation for bones, which is a therapeutic intervention.
No
The device is described as an internal fixation for bones, specifically a small bone screw, which is a therapeutic device used in surgery, not a diagnostic device.
No
The device description explicitly states it is a "small bone screw" and is compared to a "mini-fragment bone screw," both of which are physical hardware devices used for internal fixation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "small bone screw" used for "internal fixation for bones." This is a surgical implant used directly within the body, not a test performed on a sample outside the body.
- Intended Use: While the "Intended Use / Indications for Use" section is "Not Found," the "Device Description" provides enough information to understand its function, which is clearly not an in vitro diagnostic test.
Therefore, based on the provided information, the device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes mini-fragment bone screw
Reference Device(s)
Not Found
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
ALG 23 1000
Image /page/0/Picture/2 description: The image shows the logo for Orthopaedic Biosystems LTD., Inc. The logo consists of the letters OBL stacked on top of each other. The letters are in a bold, sans-serif font and are black in color. The text "ORTHOPAEDIC BIOSYSTEMS LTD., INC." is written below the logo.
Small Bone Screw 510(k)Summary Safety and Effectiveness
The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.