Shoulder Device Testing

We can help you gain regulatory approval for your shoulder devices

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Resistance to Torque Off Head Fixation of Modular Humeral Prostheses   A 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.
Resistance to Static Load of Ceramic Humeral Heads and Glenospheres   A 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.
Wear of Total Shoulder Prostheses

Wear performance of shoulder replacements is assessed via loading and displacement parameters associated with activities of daily living, defined in literature and through client-specified protocols. Up to 12 TSR implants can be assessed through the use of OIC’s AMTI hip simulator. Both anatomic and reverse systems can be tested. Samples complete 5 million cycles of testing, and wear is measured through gravimetric analysis. Typical add-ons for this test are accelerated aging of polyethylene components (ASTM F2003), wear particle characterization (ASTM F1877), surface roughness characterization, and CMM measurement to evaluate dimensional changes resulting from the test. Adverse condition testing is also commonly performed to evaluate TSR device performance under non-ideal conditions such as increased force, different motions, and roughened or pre-damaged articular surfaces.
Evaluation of Glenoid Loosening   Test 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.
Static Test of Glenoid Locking Mechanism

Describes 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.
Standard Specification for Shoulder Implants

Provides general specifications for total shoulder replacement (TSR) and defines minimum surface finish specifications of the articulating surfaces.
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