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

Ascension Orthopedics — Predicate Candidate Screening

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

91 daysmedian FDA review time

346 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182878	Integra Salto Total Ankle System	Ascension Orthopedics	2018-12-18	64	0
K162153	Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixa	Ascension Orthopedics	2017-07-14	346	0
K160830	Integra External Fixation System	Ascension Orthopedics	2016-07-06	103	0
K152047	INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid	Ascension Orthopedics	2015-12-23	153	0
K152527	Integra DigiFuse Cannulated Intramedullary Fusion System	Ascension Orthopedics	2015-10-29	56	0
K151459	Integra Total Ankle Replacement System	Ascension Orthopedics	2015-08-31	91	1
K142413	TITAN Modular Total Shoulder System	Ascension Orthopedics	2014-11-14	78	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