Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Acute Innovations, LLC — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

63 daysmedian FDA review time

144 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120163	ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM	Acute Innovations, LLC	2012-02-17	29	0
K113318	ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM	Acute Innovations, LLC	2012-01-12	63	1
K101170	ACUTE INNOVATIONS STERNAL FIXATION SYSTEM	Acute Innovations, LLC	2010-09-17	144	0
K081588	RE-ZORB PLATING SYSTEM	Acute Innovations, LLC	2008-09-03	90	0
K061206	ACUTE BONE SCREW	Acute Innovations, LLC	2006-06-19	49	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda