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

Stryker Corporate — Predicate Candidate Screening

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

182 daysmedian FDA review time

260 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153240	Styrker OrthoMap Express Knee System	Stryker Corporate	2016-07-07	241	0
K143597	Navigated XIA 4.5 Polyaxial Screwdriver	Stryker Corporate	2015-09-04	260	0
K141941	SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-	Stryker Corporate	2014-10-31	106	0
K141551	PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFE	Stryker Corporate	2014-09-08	89	1
K131214	CRANIAL MAP NEURO	Stryker Corporate	2013-10-18	172	0
K130874	STRYKER NAV3I PLATFORM	Stryker Corporate	2013-09-27	182	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