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

Stryker Corporation — Predicate Candidate Screening

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

94 daysmedian FDA review time

196 days90th percentile

81clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232157	Connected OR Hub with Device and Voice Control, SDC4K Inform	Stryker Corporation	2023-08-18	29	0
K223770	Sonopet 1Q 3 7cm 1Q Large	Stryker Corporation	2023-02-16	63	0
K212194	Stryker Q Guidance System with Cranial Guidance Software, Cr	Stryker Corporation	2023-02-16	582	1
K221728	Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate	Stryker Corporation	2022-10-19	127	0
K221074	OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinf	Stryker Corporation	2022-09-16	157	0
K221098	Scopis ENT Software, Scopis ENT Software with TGS, Scopis Pl	Stryker Corporation	2022-07-12	89	1
K213824	Sonopet iQ Ultrasonic Aspirator System	Stryker Corporation	2022-02-03	57	0
K212055	Connected OR Hub with Device and Voice Control	Stryker Corporation	2021-12-16	168	0
K210377	Stryker iBur hubs and cutting accessories	Stryker Corporation	2021-06-30	141	10
K202964	iBed Wireless with iBed Mobile	Stryker Corporation	2021-06-18	261	0
K211490	Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plu	Stryker Corporation	2021-06-09	27	0
K202393	SpineJack Expansion Kit	Stryker Corporation	2020-10-20	60	0
K202609	Instrument Clamps Electromagnetic	Stryker Corporation	2020-10-09	30	0
K201585	Monterey AL Interbody System	Stryker Corporation	2020-08-10	60	4
K200613	Tritanium® X TL Expandable Curved Posterior Lumbar Cage	Stryker Corporation	2020-04-15	37	0
K192818	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augm	Stryker Corporation	2020-03-31	182	0
K200493	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zipper	Stryker Corporation	2020-03-21	22	0
K191049	Stryker MIS and Footed Attachments	Stryker Corporation	2019-06-18	60	0
K190070	Sonopet iQ Ultrasonic Aspirator System	Stryker Corporation	2019-04-11	86	0
K183196	Stryker Navigation System with SpineMap Go Software Applicat	Stryker Corporation	2019-02-14	87	0
K181752	Stryker iVAS Elite Inflatable Vertebral Augmentation System	Stryker Corporation	2018-12-21	172	0
K180327	Stryker iVAS 13g Bone Biopsy Kit	Stryker Corporation	2018-02-26	20	0
K172116	Stryker iVAS Elite Inflatable Vertebral Augmentation System	Stryker Corporation	2018-01-25	196	0
K172034	Stryker Spine Navigation System with SpineMap 3D software ap	Stryker Corporation	2017-10-18	105	0
K172724	XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory	Stryker Corporation	2017-10-10	29	0
K172558	iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g	Stryker Corporation	2017-10-05	42	0
K171840	Stryker Consolidated Operating Room Equipment (CORE) 2 Conso	Stryker Corporation	2017-09-15	87	0
K171807	ES2 Neuromonitoring Accessory Instruments	Stryker Corporation	2017-07-18	29	0
K170242	MultiGen™ 2 RF Generator System	Stryker Corporation	2017-05-25	119	0
K170496	Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument	Stryker Corporation	2017-05-16	88	0
K162937	Stryker OrthoMap Versatile Hip System	Stryker Corporation	2017-02-23	126	0
K162929	Stryker Navigation System with CranialMap software applicati	Stryker Corporation	2017-02-22	126	0
K161514	Precision Thin Reciprocating Blade, 0.010in.	Stryker Corporation	2017-01-17	229	0
K162062	AVAmax Vertebral Balloon, AVAflex Vertebral Balloon	Stryker Corporation	2016-11-01	98	0
K160715	AccuLIF TL and PL Cage	Stryker Corporation	2016-07-08	115	0
K160978	LITe BIO Delivery System	Stryker Corporation	2016-07-08	92	0
K160050	SERFAS 90-S Electrosurgical Probe	Stryker Corporation	2016-05-03	113	0
K153407	Stryker Neptune 3 Waste Management System	Stryker Corporation	2016-04-25	152	1
K160693	Neptune E-SEP Smoke Evacuation Pencil	Stryker Corporation	2016-04-13	30	0
K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient	Stryker Corporation	2016-03-31	261	0
K153679	Stryker Neptune E-SEP Smoke Evacuation Pencil	Stryker Corporation	2016-01-22	32	0
K151726	AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEE	Stryker Corporation	2016-01-20	208	0
K152651	AccuLIF TL and PL Cage	Stryker Corporation	2015-12-15	90	0
K152632	XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Ac	Stryker Corporation	2015-12-02	78	0
K152641	Pi Drive Plus Motor, Extender	Stryker Corporation	2015-11-20	66	0
K150700	ACP 1 Anterior Cervical Plating System	Stryker Corporation	2015-07-15	119	0
K151755	OASYS(r) System	Stryker Corporation	2015-07-09	10	0
K150582	Vertaplex® High Viscosity (HV) Radiopaque Bone Cement	Stryker Corporation	2015-06-12	95	1
K150753	OASYS System	Stryker Corporation	2015-06-09	78	0
K150801	Stryker Maestro Air Motors	Stryker Corporation	2015-05-22	57	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