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

Axya Medical, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time

204 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K070773	AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR	Axya Medical, Inc.	2007-10-11	204	0
K070253	AXYA SUTURE WELDING SYSTEM AND KIT	Axya Medical, Inc.	2007-07-11	166	0
K063194	TUFFLEX POLYESTER SUTURE	Axya Medical, Inc.	2006-12-04	45	0
K060165	AXYAFLEX POLYESTER SUTURE	Axya Medical, Inc.	2006-09-01	221	0
K060970	AXYALOOP NONABSORBABLE BONE ANCHOR	Axya Medical, Inc.	2006-07-05	89	21
K052491	AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR	Axya Medical, Inc.	2005-10-07	25	21
K051983	MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR	Axya Medical, Inc.	2005-08-05	14	21
K051250	AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR	Axya Medical, Inc.	2005-06-09	24	0
K041698	AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE A	Axya Medical, Inc.	2004-10-05	105	0
K022207	AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM	Axya Medical, Inc.	2002-10-04	88	0
K021929	AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGIC	Axya Medical, Inc.	2002-09-10	90	0
K011912	MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000	Axya Medical, Inc.	2001-08-31	73	0
K003971	AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR	Axya Medical, Inc.	2001-03-21	89	0
K002557	SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)	Axya Medical, Inc.	2000-10-06	50	0
K002435	MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KI	Axya Medical, Inc.	2000-08-24	15	0
K994313	MODIFICATION TO BONE ANCHOR AND KIT (BAK)	Axya Medical, Inc.	2000-01-13	22	0
K992405	AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)	Axya Medical, Inc.	1999-09-22	64	0
K983108	SUTURE WELDING SYSTEM AND KIT (SWK)	Axya Medical, Inc.	1998-11-27	84	0
K980988	AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(A	Axya Medical, Inc.	1998-05-11	55	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