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

Stryker Orthopaedics — Predicate Candidate Screening

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

90 daysmedian FDA review time

188 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211703	Insignia Hip Stem	Stryker Orthopaedics	2021-08-16	74	0
K191414	EXETER Centralizer, EXETER 2.5mm Plug	Stryker Orthopaedics	2019-08-28	92	0
K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Hea	Stryker Orthopaedics	2018-03-19	126	0
K173849	Triathlon Total Knee System	Stryker Orthopaedics	2018-02-02	45	3
K172326	Triathlon Total Knee System, Triathlon PKR System, Restoris	Stryker Orthopaedics	2017-10-30	90	1
K153345	Stryker Orthopaedics Hip Systems Labeling Update	Stryker Orthopaedics	2016-05-25	188	1
K151264	Restoration Anatomic Shell	Stryker Orthopaedics	2015-08-10	89	16
K143085	Stryker Orthopaedics Acetabular Shells, Femoral Stems and To	Stryker Orthopaedics	2015-02-09	105	0
K143393	Triathlon Tritanium Cone Augments	Stryker Orthopaedics	2015-01-13	48	0
K142462	Restoration Anatomic Shell	Stryker Orthopaedics	2014-11-14	73	0
K141056	TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS	Stryker Orthopaedics	2014-08-05	103	3
K132624	TRIATHLON TRITANIUM METAL-BACKED PATELLA	Stryker Orthopaedics	2013-11-26	96	1
K072575	TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE	Stryker Orthopaedics	2008-01-07	116	0
K070170	DALL-MILES SYSTEM	Stryker Orthopaedics	2007-03-02	43	0
K063816	PCA ALUMINA FEMORAL HEADS	Stryker Orthopaedics	2007-02-02	42	0
K063822	MODIFICATION TO HIPSTAR FEMORAL STEM	Stryker Orthopaedics	2007-01-25	30	1
K062553	SIMPLEX P BONE CEMENT	Stryker Orthopaedics	2007-01-08	131	0
K051223	HIPSTAR FEMORAL STEM	Stryker Orthopaedics	2006-05-10	363	1
K053514	TRIATHLON TOTAL KNEE SYSTEM	Stryker Orthopaedics	2006-01-26	41	2
K053528	SHORT CITATION FEMORAL STEM	Stryker Orthopaedics	2006-01-13	25	0
K052542	ACCOLADE RPS HIP STEM	Stryker Orthopaedics	2005-09-27	12	0
K051741	ACCOLADE HFX FEMORAL STEM	Stryker Orthopaedics	2005-09-26	90	0
K040432	SOLAR 2 ANATOMIC SHOULDER	Stryker Orthopaedics	2005-01-07	323	0
K040412	TRIDENT T ACETABULAR SHELLS	Stryker Orthopaedics	2004-05-25	97	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