We help our clients gain regulatory approval for shoulder medical devices
We offer a broad range of static, dynamic, computational, and wear testing services for anatomical and reverse should replacement devices. All of our test procedures follow international test standards as described below.
Our engineering team is active in ASTM and ISO arthroplasty standards committees to ensure the latest industry best-practices are applied to your test. If a non-standard test is needed, our engineering team will develop and incorporate modifications to suit your specific device and data needs.
Having a strong foundation in clinical research provides you with the additional value of a clinically-relevant test procedure. We pride ourselves on the ability to meet a customer’s specific needs with a wholly unique, tailored solution.
Standard Specification for Shoulder ImplantsProvides general specifications for total shoulder replacement (TSR) and defines minimum surface finish specifications of the articulating surfaces.
Static Test of Glenoid Locking MechanismDescribes a method for testing the static shear disassembly force of glenoid TSR components. A constant displacement rate is applied to five samples in the inferior-superior position, and five samples in the anterior-posterior direction until disassembly occurs.
Evaluation of Glenoid LooseningTest method for evaluating the displacement of a glenoid TSR component after cyclic loading applied to the opposing rims of the glenoid component. Test is applicable to both standard and reverse shoulder implants and also evaluates the locking mechanism of modular glenoid or humeral components.
Anatomical Total Shoulder Prostheses Wear TestWear performance of anatomical total shoulder replacements can be tested on OIC's AMTI hip simulator. An ISO working draft remains under development, awaiting an official release.
Reverse Total Shoulder Prostheses Wear TestWear performance of reverse total shoulder replacements is tested on OIC's AMTI hip simulator. Force and displacement parameters suitable for reverse total shoulder prostheses are applied to completion of 2.5 million cycles or until mechanical failure of the articulating surfaces is observed. An ISO working draft remains under development, awaiting an official release.
Resistance to Static Load of Ceramic Humeral Heads and GlenospheresA humeral head is assembled onto the humeral stem taper using the specified assembly force. Load is applied to the humeral head at a user-specified angle to the humeral stem taper until the humeral head fractures or the maximum specified load is reached.
Resistance to Torque Off Head Fixation of Modular Humeral ProsthesesA humeral head is assembled onto the humeral stem taper using the specified assembly force. Torsion is applied to the humeral head while holding the stem rigid until movement of the head occurs. The peak torsion is recorded as the loosening torque.