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The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   The device is a single use implant.

The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.

The provided 510(k) summary for the Biomet Vanguard™ PS Open Box Porous Femoral Components explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, based on the provided document, the device did not undergo clinical testing to demonstrate its performance against specific acceptance criteria. Instead, it relied on an engineering justification including a Finite Element Comparison to show it was "functional within its intended use" and claimed substantial equivalence to legally marketed predicate devices (Maxim® Accel Knee System K023546 and Non-Cemented Porous Coated Knees K033489).

As such, I cannot provide information on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods, as these elements are typically part of a clinical study.

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