(72 days)
Indications for use for the Smith & Nephew External Fixation System are as follows:
- Post-traumatic joint contracture which has resulted in loss of range of motion. ●
- Fractures and disease which generally may result in joint contractures or loss of range of motion and . fractures requiring distraction.
- Open and closed fracture fixation. ●
- Pseudoarthrosis of long bones. .
- Limb lengthening by epiphyseal or metaphyseal distraction. ●
- Correction of bony or soft tissue deformities. .
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis. .
- Infected fractures or nonunions. ●
- Management of comminuted intra-articular fractures of the distal radius. .
The Smith & Nephew Unilateral External Fixator is a unilateral external fixation device used for the indications listed previously. Major components are made of aluminum, stainless steel and composite materials with some fastener components made from bronze or rubber. These materials are similar to those used in other legally marketed unilateral fixators.
The Smith & Nephew Unilateral Wrist Fixators are unilateral external fixation devices used for the indications listed previously. All components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed unilateral wrist fixators.
The Smith & Nephew Proximal Interphalangeal (PIP) Joint Hinge is a unilateral fixation device used for the indications listed previously. Major components are made from a radiolucent, non-reinforced thermoplastic. Various other components and fasteners are made from stainless steel. These materials are similar to those used in other legally marketed unilateral fixators.
The Smith & Nephew Multilateral External Fixation System is a multilateral fixation device used for the indications listed previously. Major components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed multilateral fixators.
The Taylor Spatial Frame External Fixation System is a multilateral fixation device used for the indications listed previously. Major components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed multilateral fixators.
The Smith & Nephew Ankle Hinge Fixator is used with either al or multilateral fixation device for the indications listed previously. Major components are made from composite and stainless steel materials. These materials are similar to those used in other legally marketed unilateral or multilateral fixators.
This document is a 510(k) summary for the Smith & Nephew External Fixation System, seeking substantial equivalence to predicate devices already on the market. It does not describe an AI/ML device or a study involving performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device. The document explicitly states: "The safety and effectiveness of external fixators is based on the long history of use of these devices in the orthopedic market place." This indicates that the device's approval is based on its similarity to existing, legally marketed devices, rather than a new performance study with specific acceptance criteria as you've outlined for an AI/ML product.
§ 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.