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

Stryker Leibinger — Predicate Candidate Screening

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

105 daysmedian FDA review time

290 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052871	STRYKER CUSTOM TI IMPLANT	Stryker Leibinger	2005-12-16	66	0
K043250	STRYKER PATIENT SPECIFIC POLYMER IMPLANT	Stryker Leibinger	2005-04-15	143	4
K041651	STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM	Stryker Leibinger	2004-09-30	105	0
K040022	STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM	Stryker Leibinger	2004-03-12	65	0
K022579	STRYKER NAVIGATION SYSTEM-KNEE MODULE	Stryker Leibinger	2003-06-02	301	7
K023449	NON-INVASIVE PATIENT FIXATION SYSTEM	Stryker Leibinger	2003-01-13	90	0
K013775	TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM	Stryker Leibinger	2002-01-08	56	0
K012380	MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSC	Stryker Leibinger	2001-12-03	130	0
K000594	LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE	Stryker Leibinger	2000-12-08	290	0
K000348	COLORADO MICRODISSECTION NEEDLE	Stryker Leibinger	2000-05-03	90	0
K000349	MOTORIZED MICRO MULTILEAF COLLIMATOR	Stryker Leibinger	2000-05-03	90	0
K991398	BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT	Stryker Leibinger	1999-09-22	153	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