Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Stryker — Predicate Candidate Screening

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

92 daysmedian FDA review time

185 days90th percentile

92clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231854	1788 4K Camera System with Advanced Imaging Modality; L12 LE	Stryker	2023-09-20	89	0
K230416	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®	Stryker	2023-05-19	92	0
K230754	L12 LED Light Source with AIM	Stryker	2023-04-11	25	0
K230605	1788 4K Camera System with Advanced Imaging Modality	Stryker	2023-03-31	28	0
K230216	1688 4K Camera Control Unit with Advanced Imaging Modality (	Stryker	2023-02-23	28	0
K222130	1688 4K Camera System with Advanced Imaging Modality	Stryker	2022-08-19	32	0
K220731	Insignia Hip Stem, Restoration Modular 115mm Conical Distal	Stryker	2022-08-11	150	0
K221611	780 nm L11 LED Light Source with AIM	Stryker	2022-06-29	26	0
K221217	SPY Laparoscope	Stryker	2022-06-17	51	0
K214046	780 nm 1688 4K Camera System, 780 nm L11 LED Light Source wi	Stryker	2022-05-25	149	0
K220895	1688 4K Camera Control Unit with Advanced Imaging Modality (	Stryker	2022-04-22	25	0
K212511	1688 4K Camera Control Unit with Advanced Imaging Modality (	Stryker	2021-11-04	86	0
K211202	1688 4K Camera System, L11 LED Light Source with AIM, AIM Sa	Stryker	2021-08-06	106	0
K210088	1688 4K Camera System, L11 LED Light Source with AIM, AIM Sa	Stryker	2021-04-13	90	0
K210584	SDC3 HD Information Management System with Wireless Device C	Stryker	2021-03-18	20	0
K203055	Stryker PEEK Customized Cranial Implant Kit	Stryker	2021-02-09	124	0
K202659	Stryker Arthroscope	Stryker	2020-12-01	78	0
K202355	Stryker Omega PEEK Knotless Anchor System	Stryker	2020-11-13	86	0
K202592	Adavanced Imaging Modality System (1688 4K Camera System Wit	Stryker	2020-10-08	30	0
K201434	Connected OR Hub with Voice Control, Connected OR Hub with D	Stryker	2020-07-28	57	0
K193143	Stryker Facial iD Plating System	Stryker	2020-03-26	134	0
K193136	Stryker Customized Mandible Recon Plate Kit	Stryker	2020-03-26	134	0
K200310	1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4	Stryker	2020-03-06	29	0
K200117	Trevo NXT ProVue Retriever	Stryker	2020-02-07	17	0
K192122	Trevo Trak 21 Microcatheter	Stryker	2019-11-22	108	0
K192207	Trevo NXT ProVue Retriever	Stryker	2019-11-22	100	0
K192292	L10 LED Light Source with AIM, L11 LED Light Source with AIM	Stryker	2019-11-19	88	0
K192172	Connected OR Hub with Device and Voice Control	Stryker	2019-09-09	28	0
K191102	Precision S 4K Sinuscope	Stryker	2019-09-06	134	0
K190229	Stryker PEEK Customized Cranial Implant Kit	Stryker	2019-07-11	156	0
K190696	Stryker Surgeon iD Mandible Recon Plate	Stryker	2019-06-28	102	0
K190779	Trevo XP ProVue Retriever	Stryker	2019-06-25	90	1
K190172	Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachmen	Stryker	2019-06-14	133	0
K183381	Navigation Enabled Instruments	Stryker	2019-05-17	162	0
K191046	L10 LED Light Source with AIM, L11 LED Light Source with AIM	Stryker	2019-05-10	21	0
K190843	Synchro2 Support Guidewire	Stryker	2019-05-01	30	8
K183463	AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalys	Stryker	2019-03-13	89	0
K183464	AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 12	Stryker	2019-03-13	89	0
K183172	Stryker SternalPlate System	Stryker	2019-03-05	109	0
K183470	Precision Ideal Eyes Arthroscopes	Stryker	2019-01-07	24	0
K182305	Stryker Facial iD Plating System	Stryker	2019-01-07	136	0
K181258	ConnectedOR Hub with Device and Voice Control	Stryker	2018-11-05	178	0
K182160	1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount	Stryker	2018-11-05	88	1
K181504	Stryker Pediatric Mandibular Distractor 2	Stryker	2018-09-11	96	0
K181083	Stryker All-PEEK Knotless Anchor System	Stryker	2018-07-23	90	2
K173074	ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor	Stryker	2018-04-04	187	0
K173841	AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalys	Stryker	2018-03-18	90	0
K171391	Stryker 90-S Max SERFAS Energy Probe	Stryker	2018-01-26	260	0
K173866	Stryker AIM Light Source and SafeLight cable	Stryker	2018-01-18	29	0
K173476	Tritanium® TL Curved Posterior Lumbar Cage	Stryker	2018-01-18	70	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