The Instratek Cannulated Titanium Bone Screw System consists of self-tapping, self-threading screws intended in the treatment of unstable fractures and osteotomies in bones and interfragmentary indications and specific long bone indications.

The screws are self-tapping and self-threading to simplify implantation. An internal hex-head allows for maximum torque with minimal risk of stripping.

Instrumentation is provided to assist in the surgical implantation of the Instratek Screws. It is important that the instruments used are those specifically designed for this device to ensure accurate installation.

The Instratek 2 mm and 3 mm bone screws are indicated for use in the treatment of unstable fractures and osteotomies in small bones and interfragmentary indications and specific long bone indications. These devices are not intended for use in the spine. They are indicated for:

The Instratek 4 mm bone screws are indicated for use in the treatment of unstable fractures and osteotomies in small bones and specific long bone indications. These devices are not intended for use in the spine. They are indicated for:

Bone screws are contraindicated for use in patients with the following conditions:

For safe and effective use of these implant systems, the surgeon should be familiar with the recommended surgical procedure for these devices (see the Surgical Protocol, INS P/N 81-0005). Improper selection, placement, positioning, or fixation of the implant may result in unusual loading conditions which could affect the long term service life of the implant (s).

In every case, accepted surgical practices should be followed in post-operative care. The patient should be made aware of the limitations of the bone screw and that physical activity and full weight bearing have been implicated in premature failure of similar devices.

Patient sensitivity to implant materials should be considered and assessed prior to surgery.

The following are specific adverse effects which should be understood by the surgeon and explained to the patient. These do not include all adverse effects which can occur with surgery in general, but are important considerations particular to metallic internal stabilization devices. General surgical risks should be explained to the patient prior to surgery.

The Instratek bone screws are manufactured from titanium alloy (TI-6Al-4V ELI, ASTM F136).

Each of the Instratek bone screws should be received in an intact package. Damaged packages or products should not be used and should be returned to Instratek.

Unless supplied sterile and clearly labeled as such, all screws must be steam autoclaved prior to use in surgery. The Instratek bone screws and instruments may be steam sterilized by the hospital using the following process parameters:

Method: Steam

Cycle: Gravity

Temperature: 270 F (132 C)

Exposure Time: 30 minutes

Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Immediately re-sterilize all implants and instruments removed from the surgical field before handling.

Surgical implants should not be re-used. Any implant once used should be discarded. Even though it may appear undamaged, the implant may have small defects or internal stress patterns which may lead to failure.

Store implants unopened in their respective protective packaging until use. When removing the implant from its packaging, observe all relevant aseptic instructions. Protect the prosthesis from contact with objects which may damage the surface finish. Inspect each implant prior to use and dispose of implants that exhibit surface of configuration damage.

Contouring or clamping of implants should be avoided if possible. It is recommended that the implants should not be cut, sharply bent or re-bent, notched or scratched. These alterations can produce defects or stresses which may lead to failure of the implant.

Federal Law (USA) restricts this device to sale by or on the order of a physician.