510(k) Report

FDA product code · Orthopedic

Medial Knee Implanted Shock Absorber

QVVClass II21 CFR 888.3610510(k) required1 decision since 20231 recall

1 FDA decision since 2023. 1 recall names this code; it is not Class I.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of QVV at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QVV

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QVV

Too few QVV 510(k)s in any year since 2007 to give a median.

Recalls per year · QVV

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QVV

10in 2025

2024: 32025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code QVV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—13
20250—010
20260—0—
FIG. 1 — QVV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QVV? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report