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

Orthopro, LLC — Predicate Candidate Screening

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

136 daysmedian FDA review time

418 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122936	ANKLE TRAUMA SYSTEM	Orthopro, LLC	2013-02-28	157	0
K113006	I-FUSE HAMMER TOE SYSTEMS	Orthopro, LLC	2012-05-25	231	0
K093055	CSTS SCREW	Orthopro, LLC	2010-11-22	418	0
K073228	DC ULNAR SHORTENING SYSTEM	Orthopro, LLC	2008-02-29	106	0
K070555	ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES	Orthopro, LLC	2007-07-13	136	0
K071243	METAL HEMI IMPLANT	Orthopro, LLC	2007-05-23	20	1
K062908	ORTHROPRO HEMI TOE	Orthopro, LLC	2006-11-13	47	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