(52 days)
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine.
The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications:
- Metatarsal fractures
- Fixation of malunions and nonunions
- Acute fractures
- Avulsion fractures
- Repetitive stress fractures
- Malleolar fractures
- Talus fractures
- Greater tuberosity fractures
- Small joint fusion
- Jones fractures
- Osteotomies and non-unions in the foot and ankle
The Instratek Jones-FX System is comprised of screws in diameters 4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated and non-cannulated versions and are constructed of TI-6AL-4V anodized titanium alloy conforming to ASTM F136. The screws have Torx heads. Instruments provided in the set include: Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy
The provided text is for a 510(k) summary for a bone screw system (Instratek Jones-FX System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy or performance through extensive studies with acceptance criteria as one might see for novel diagnostic AI devices.
Based on the provided information, no study was conducted to prove the device meets acceptance criteria. The submission explicitly states:
"No testing was conducted for inclusion with this submission."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the submission does not contain such a study. The basis for substantial equivalence is the similarity in design, materials, intended use, and technological characteristics to predicate devices, not through performance testing against specific acceptance criteria.
§ 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.