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

HTO — Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

32 daysmedian FDA review time

147 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111437	SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)	Synthes (USA) Products, LLC	2011-08-10	78	2
K042899	SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS	Synthes (Usa)	2005-03-16	147	1
K013527	MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RI	Synthes (Usa)	2001-12-21	59	1
K993335	SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM	Synthes (Usa)	2000-06-12	252	0
K954915	FLEXIBLE INTRAMEDULLARY REAMER	Zimmer, Inc.	1995-12-28	63	0
K903248	COMBINATION REAMER	Onyx Medical Corp.	1990-07-30	6	0
K885100	MCCONNELL REAMER GUIDE	Mcconnell Orthopedic	1989-01-13	32	0
K870845	WARSAW ORTHOPEDIC POINTED REAMER	Warsaw Orthopedic, Inc.	1987-03-11	8	0
K862933	ABC-1000 SMALL JOINT REAMERS	Instrumentation Industries, Inc.	1986-08-18	14	0
K832686	MULTIPLE MANUAL SURGICAL INSTRUMENTS	Hirata Sangyo Co. USA, Inc.	1983-10-14	73	0
K811081	MEDULLARY CANAL SCRAPERS	The Anspach Effort, Inc.	1981-04-29	8	0
K790996	C.C.F. FEMORAL DEBRIDEMENT PROBE	Depuy, Inc.	1979-06-27	29	0
K790307	FLEXIBLE REAMER, GUIDE WIRE SYSTEM	3M Company	1979-02-22	9	0
K770203	HAND REAMERS	Depuy, Inc.	1977-02-08	8	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