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

Ortho Development — Predicate Candidate Screening

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

103 daysmedian FDA review time

118 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141001	ALPINE HIP STEM; ALPINE HA HIP STEM	Ortho Development	2014-07-30	103	0
K111965	VUSION(R) OS	Ortho Development	2011-10-25	106	0
K111936	ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD	Ortho Development	2011-09-21	75	0
K103837	BALANCED KNEE SYSTEM REVISION OFFSET TIBIA	Ortho Development	2011-03-24	84	0
K103384	ESCALADE ACETABULAR CUP SYSTEM	Ortho Development	2011-03-16	118	1

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