FDA product code · Orthopedic

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Name: FDA decisions, review times, recalls and adverse event reports for product code QRR
Creator: 510(k) Report

QRRClass II21 CFR 888.3046510(k) required2 decisions since 20220 recalls

2 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 85 days (half between 85 and 85). No recall names this code. The most-cited predicate is DEN210044, named by 1 later device.

A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.

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 QRR 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 · QRR

1in 2024

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRR

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

Recalls per year · QRR

No recall names QRR since 2007.

Adverse event reports per year · QRR

3in 2025

2007high 3 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	1
2024	1	—	0
2025	0	—	3
2026	0	—	—

FIG. 1 — QRR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QRR? 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

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Which predicates do QRR devices cite most?

Which QRR devices have the deepest lineage?

What has FDA decided in QRR lately?