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

Hand Innovations, LLC — Predicate Candidate Screening

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

27 daysmedian FDA review time

59 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061748	FRAGMENT PLATE SYSTEM	Hand Innovations, LLC	2006-07-17	26	0
K060864	MULTIDIRECTIONAL THREADED PEG	Hand Innovations, LLC	2006-04-28	29	0
K060294	DIAPHYSEAL PLATE	Hand Innovations, LLC	2006-03-22	44	0
K060290	SHOULDER FIXATION SYSTEM	Hand Innovations, LLC	2006-02-27	21	0
K052294	SHOULDER NAIL PLATE	Hand Innovations, LLC	2005-10-21	59	0
K052248	DORSAL NAIL PLATE, ANATOMICAL	Hand Innovations, LLC	2005-09-14	27	5
K051728	MODIFICATION TO SHOULDER FIXATION SYSTEM	Hand Innovations, LLC	2005-07-20	23	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