Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430, USA
A subsidiary of Stryker Corporation
Telephone #: +1 201-831-5000
©2012 Howmedica Osteonics Corp.
QIN4333 Rev E
ZAC Satolas Green Pusignan
Av de Satolas Green
Attention, See Instructions for Use
Do not Reuse
Sterilized using Irradiation
Sterilized using Hydrogen Peroxide
Sterilized using Ethylene Oxide
Use by Date
Date of Manufacture
Authorized Representative in the European Community
4333 Rev. E
HOWMEDICA OSTEONICS Instrumentation consists of manual surgical instruments intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, spinal fusion or trauma surgeries.
Before clinical use, the surgeon must thoroughly understand all aspects of the surgical procedure and the limitations of the instrumentation.
HOWMEDICA OSTEONICS Trial Components should be used for size determination, preparation evaluation, trial reduction and range of motion evaluation, thus helping to preserve the
integrity of the actual implants and their sterile packaging.
Radiographic templates are available to help assist in the preoperative prediction of component size and style.
The Howmedica Osteonics Corp. Surgical Protocols provide additional procedural information.
Care must be taken not to cut through surgical gloves when handling any sharp-edged orthopaedic device.
Due to different manufacturers employing differing design parameters, varying tolerances, different materials and manufacturing specifications, HOWMEDICA OSTEONICS instrumentation
should not be used to implant any other manufacturer’s components. Any such use will negate the responsibility of Howmedica Osteonics Corp. for the performance of the resulting implant.
Instruments made of non-metallic material(s) and fragments thereof may not be visible using certain forms of external imaging (e.g. x-ray) unless otherwise specified, such as radiopaque
femoral head trials.
Malfunctions of instruments, including, but not limited to, weld fracture, thread galling and material fatigue, have occurred in a small percentage of cases.
Serious complications may be associated with any joint replacement, spinal or trauma surgery. These complications include, but are not limited to: genitourinary disorders; gastrointestinal
disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; myocardial infarction or death.
Peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone formation may occur.
Intraoperative fissure, fracture, or perforation of the bone can occur due to numerous factors including the presence of defects, poor bone stock, the use of the surgical instruments and the
impaction of the component into the preparation.
Cleaning and Sterilization
This reusable instrument is not sterile.
Remove all instruments from their packaging prior to cleaning and sterilization.
All parts must be cleaned and sterilized before use. Cleaning of the reusable instrument prior to sterilization should include: presoaking, manual cleaning, ultrasonication (e.g. for complex
parts), and washing/disinfecting. Enzymatic cleaners, manual detergents, and neutral cleaners should be used.
During and after cleaning, inspect hard-to-reach areas such as lumens within the instrument to help ensure that entrapped debris and/or soil are completely removed. If debris and/or soil are
evident, then reclean the instrument until there is no evidence of debris and/or soil.
Rinsing should be performed after each cleaning step to help ensure cleaners and/or debris/soil are removed.
Howmedica Osteonics’ reusable instruments are recommended to be sterilized by moist heat sterilization.
Instruments with articulating surfaces must be tested for movement. A moist heat compatible, medical grade lubricant should be applied to all articulating joints prior to sterilization.
After cleaning and prior to sterilization, the reusable instrument should be double-wrapped or packaged in CSR sterilization wraps or pouches. Wrapping should be performed using the
appropriate wrapping method (e.g. AAMI CSR wrapping technique).
Biological indicators and/or steam integrators should be used within the sterilizer load to help ensure the proper sterilization conditions of time, temperature, and saturated steam have been
The parameters for sterilization are:
270° F (132° C)
30 minutes (minimum, in chamber)
60 minutes (minimum, at room temperature)
Howmedica Osteonics Corp. has validated the above recommended sterilization cycle based on AAMI/ANSI/ISO guidelines and recommendations. Other sterilization methods and cycles may also
be suitable. However, individuals or hospitals are advised to validate whichever method they deem appropriate at their institution.
EtO sterilization and cold sterilization techniques are not recommended.
Detailed manual and automatic cleaning instructions, including times and temperatures, are provided in Stryker Orthopaedics Literature LSTPI-B available at
www.stryker.com/orthopaedics/cleaning. Disassembly and assembly instructions applicable to all Stryker Orthopaedics re-usable instruments are all also provided in this brochure.
Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademark(s) or service mark(s): Howmedica, Osteonics, Stryker. All
other trademarks are trademarks of their respective owners or holders.
Refer to product label for CE Mark Status and Legal Manufacturer. The CE mark is only valid if also found on the product label.
The following table contains a list of abbreviations that are used on Howmedica Osteonics Corp. product labeling:
DEG or °