FDA product code QVV: Medial Knee Implanted Shock Absorber

QVV is the FDA product code for medial knee implanted shock absorber. It is a Class II device, regulated under 21 CFR 888.3610 and reviewed by the Orthopedic panel. Devices under QVV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for QVV devices, 1 initiated in the last five years.

Definition

A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.

Classification

Recalls for QVV devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-02.

Frequently asked questions

What is FDA product code QVV?

QVV is the FDA product code for medial knee implanted shock absorber. It is a Class II device, regulated under 21 CFR 888.3610 and reviewed by the Orthopedic panel.

What device class is QVV?

Class II, regulation 21 CFR 888.3610. Typical premarket route: 510(k).

Have QVV devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-02.

Next steps

• Run an FDA pathway report with predicate devices for product code QVV
• Run a recall and safety report across every QVV manufacturer
• Watch product code QVV for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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