Orthopedic Stereotaxic Instrument

What Is It?

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

How Is OLO Classified?

Orthopedic Stereotaxic Instrument is FDA product code OLO, Class 2, 21 CFR 882.4560.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 268 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 113 recalls under this product code since 2010. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Device Design (46), Software design (14) and Nonconforming Material/Component (9). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.