(214 days)
The Stryker Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm, and 4.0 mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, hand surgery, orthopedic surgery, plastic surgery, and podiatric surgery. These devices are not intended for use in the spine. The Stryker Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid fractures
- Lunate fractures
- Capitate fractures
- Trapezial fractures
- Metacarpal fractures
- Metatarsal fractures
- Phalangeal fractures
- Radial head fractures
- Ulnar styloid fractures
- Small joint fusion
- Osteochondral fractures
- Humeral head fractures
- Glenoid fractures
- Carpometacarpal joint fractures
- Interphalangeal joint fractures
- Tarsal fusions
- Malleolar fractures
- Patellar fractures
- Metaphyseal fractures
- Interfragmentary radius fractures
- Interfragmentary ulnar fractures
- Small hand and wrist bone fractures
- Distal metatarsal osteotomies
- Forefoot interfragmentary fractures
- Midfoot interfragmentary fractures
The Mini Cannulated Titanium Headed and Headless Screw Set consists of cannulated screws with diameters ranging from 2.5 mm to 4.0 mm. The cannulated screws have a torx head design and are made from anodized titanium alloy. This submission seeks to update labeling.
This document is a 510(k) premarket notification for a medical device and, as such, does not contain the kind of detailed information about acceptance criteria and comprehensive study results typically found in a clinical trial report or a performance study for an AI-powered device.
This submission is for a traditional medical device (bone screws), not an AI/ML diagnostic or prognostic tool. Therefore, questions 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are specifically tailored for AI/ML device performance studies, are not applicable to the content provided.
Here's a breakdown of why these questions cannot be answered from the provided text:
- The document states, "This submission does not require non-clinical testing" and "This submission does not require clinical testing." This explicitly indicates that no studies proving device performance against acceptance criteria were conducted or presented within this submission.
- The entire submission is focused on demonstrating "substantial equivalence" to a predicate device (K120493) based on intended use, material, design, and operational principles, rather than proving performance characteristics through novel testing against predefined acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided 510(k) summary for this type of medical device.
§ 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.