Material Specifications
The Instratek bone screws are manufactured from titanium alloy
•TI-6Al-4V ELI, ASTM F136
Manufacturer
This product is manufactured by Restore Surgical, LLC in Houston, TX.
Cannulated Titanium
Headed & Headless Screw Set
TM
Product Handling
mn
Do Not Reuse
2.5 - 3.0 - 4.0
Lot Number
R ONLY
X
Use By - Year & Month
Manufacturer
See Instructions For Use
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.
Implant Sterilization
The implant is supplied non-sterile.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
Packaging and Sterility
Each of the Instratek bone screws should be received in an intact clearly labeled package. Damaged
packages or products should not be used and should be returned to Instratek. Remove all packaging
material prior to sterilization. Only sterile implants should be used in surgery. Surgical implants
should not be re-used. Any implant once used should be discarded.
Indications for Use
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm and 4.0mm
bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthorodeses,
osteochrondritis, 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.
Unless supplied sterile and clearly labeled as such, all screws and associated instrumentation must be
steam autoclaved prior to use in surgery. The Instratek bone screws may be steam sterilized by the
hospital using the following process parameters:
Sterilization Cycle Parameters
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the
following surgical indications:
Scaphoid Fractures
Capitate
Metacarpal Fractures
Phalangeal Fractures
Ulnar Styloid Fractures
Small Joint Fusion
Humeral head Fractures
Intercarpal Fractures
Tarsal Fusions
Patellar Factures
Interfragmentary Radius Fractures
Small Hand and Wrist Bone Fractures
Forefoot Interfragmentary Fractures
Lunate Fractures
Trapezial Fractures
Metatarsal Fractures
Radial Head Fractures
Osteo-Chondral
Ostero-Chondral Fractures
Glenoid Fractrures
Interphalangeal Fractures
Malleolar Fractures
Metaphyseal Fratures
Interfragmentary Ulnar Fractures
Distal Metatarsal Osteotomies
Midfoot Interfragmentary Fractures
Sterilization Type:
Minimum Temperature:
Full Cycle Time:
Minimum Dry Time:
Prevacuum, Wrapped
132°C
4 Minutes
30 Minutes
Sterilization Type:
Minimum Temperature:
Full Cycle Time:
Minimum Dry Time:
Gravity, Wrapped
132°C
15 Minutes
30 Minutes
*The wrap should be an FDA cleared sterilization wrap such as Kimguard KC600 - 510(k) K082554
*Validated by Instratek under laboratory conditions, however, these parameters and other sterility
methods must be re-validated by the end user to ensure that sterility can be achieved on site.
*Users should validate this process in their particular environment to appropriate standards and
guidelines such as ANSI/AAMI ST79:2010/A2:2011.
Instrumentation Sterilization
Contraindications
Recommendation for care and handling of Instratek reusable instruments, instrument cases and non
sterile implants.
• Active infection.
• Poor bone quality.
• Osteoporotic bone that is susceptible to fracture.
• Conditions that limit the patient’s ability or willingness to follow postoperative
instructions with the healing regimen.
• Foreign body sensitivity or hyper reactivity.
• Physical conditions that retard the healing process.
• Surgical procedures not indicated for the device.
• Skeletally immature bone/patients may not be suitable.
For all reusable medical devices, the most important step in decontamination is thoroughly cleaning
and rinsing devices. The purpose of these cleaning and rinsing recommendations is to remove all
visible gross contamination prior to sterilization.
Cleaning and Decontamination
1. Removal of gross contaminates should be accomplished by manually submerging items in water
or mechanically, or by a combination of both methods. Either method should be effective, should not
impede functionality of the device and be safe for employee performing the task.
Warnings
For safe and effective use of these implant systems, the surgeon should be familiar with the
recommended surgical procedure for these devices. 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 Mini Cannulated Titanium Headed and Headless Screw Set has not been evaluated for safety and
compatibility in the MR environment. The Mini Cannulated Titanium Headed and Headless Screw Set
has not been tested for heating or migration in the MR environment.
2. Disassemble instruments into individual parts.
3. Instruments should be submerged in a detergent solution or the combination of detergent and
enzymatic solution. Any solution or detergent should be easily removable from the medical device
by rinsing with water so that the device does not retain residual chemicals that could harm patient or
damage device.
4. Following cleaning, instruments should be thoroughly rinsed using quality water that does not
contribute to staining.
Caution
Federal Law (USA) restricts this device to sale by or on the order of a physician
Adverse Effects
•Infection
•Pain, discomfort, or abnormal sensations due to presence of the implant
•Metal sensitivity/allergic reaction to a foreign body
•Migration of the implant, loosening of the implant
•Delayed correction in alignment
•Decrease in bone density due to stress shielding
•Bursitis
15200 Middlebrook Dr., Suite G
Houston, TX 77058
Restore Surgical, LLC
15200 Middlebrook Dr., Suite G
Houston, TX 77058
Ph: 1.800.892.8020
www.instratek.com
Ph: 800.892.8020
Fax: 281.890.8068
I-IFU-03-Rev C
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.