(45 days)
The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:
| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|---|---|---|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight | |
| polyethylene (UHMWPE) | Up to USP Size 2 | |
| 2.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 2.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 1.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 1.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |
The Multitak SS Buttons are fixation devices indicated in orthopedic fracture and in ligament and tendon repair They are intended to stabilize two or more bone hagments and distribute suture tension over the fracture site in order to facilitate healing. The buttons also serve as fixation posts for distributing surure tension over areas of ligament and renden repair The cyundneal buttons are made from titanium, polypropylene, or polyethylene and have an overali ratio of approximately 3 1, length to diameter. The buttons are available in the tollowing sizes ( ! ) ! 2 mm in diameter and 4 0 mm in length, (2) 1 8 mm in diameter and o 0 mm in length (3) 2 5 mm in diameter and 8 3 mm in length, and (4) 3 0 mm in diameter and I min in lengin The buttons are applied to the outer bone cortex over a prednilled hole across the manufe she Bone fragments are stabilized with suture running through the drill bone hole and off at the button The buttons provide linear fixation and compression of the bone trapments promoting healing at the fracture site Buttons can also be used as fixation posts and are praced outside the corucal bone in ligament and tendon repair. They provide a means of distributing suture tension over areas of repaired ligaments and tendons. The buttons are provided sterile with or without attached suture in packs of two and are not intended for reuse.
The provided text is a 510(k) Premarket Notification for the Bonutti Research, Inc. Multitak SS Buttons. This document describes a medical device (fracture fixation device and surgical buttons) and its intended use, rather than an AI/ML powered device.
Therefore, the prompt questions regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document. The submission is for a physical medical device, not a diagnostic algorithm or AI system.
§ 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.