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

Arthrocare Corp. — Predicate Candidate Screening

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

36 daysmedian FDA review time

116 days90th percentile

112clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153186	Adjustable Fixation Device	Arthrocare Corp.	2016-01-28	86	0
K131709	SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT	Arthrocare Corp.	2013-10-04	115	0
K130196	SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, P	Arthrocare Corp.	2013-02-27	30	0
K111399	SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR,	Arthrocare Corp.	2011-07-20	62	0
K111397	TITAN TI SUTURE ANCHOR SYSTEM	Arthrocare Corp.	2011-07-12	54	0
K110781	5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE	Arthrocare Corp.	2011-05-27	67	0
K110183	ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE	Arthrocare Corp.	2011-02-16	26	0
K110164	5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH T	Arthrocare Corp.	2011-02-07	19	0
K101437	SPEEDFIX SUTURE SYSTEM	Arthrocare Corp.	2010-10-29	158	0
K102262	ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EX	Arthrocare Corp.	2010-10-21	72	0
K100479	PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE	Arthrocare Corp.	2010-09-21	215	0
K101448	OPUS SPEEDSCREW SYSTEM	Arthrocare Corp.	2010-06-21	28	1
K101184	TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-	Arthrocare Corp.	2010-05-18	20	0
K100353	SPINEWAND SURGICAL DEVICE	Arthrocare Corp.	2010-05-13	90	0
K100457	OPUS SPEEDSCREW SYSTEM	Arthrocare Corp.	2010-03-19	30	0
K091674	ARTHROCARE COBLATOR IQ SYSTEM	Arthrocare Corp.	2010-01-15	220	0
K093165	ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS	Arthrocare Corp.	2009-12-04	59	0
K092133	ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 2	Arthrocare Corp.	2009-11-05	113	0
K091228	SPINEWAND SURGICAL DEVICE	Arthrocare Corp.	2009-09-28	154	0
K090393	ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCAR	Arthrocare Corp.	2009-06-23	126	0
K091503	MAGNUM MP FIXATION DEVICE	Arthrocare Corp.	2009-06-17	27	0
K090615	OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE	Arthrocare Corp.	2009-06-03	86	1
K090380	MAGNUM M FIXATION DEVICE	Arthrocare Corp.	2009-03-13	24	0
K083240	OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES	Arthrocare Corp.	2009-01-12	70	3
K083306	MODIFICATION TO ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2008-12-10	30	1
K082980	ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2008-11-05	30	12
K082666	ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CAB	Arthrocare Corp.	2008-10-15	33	0
K081893	OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-65	Arthrocare Corp.	2008-10-01	90	0
K082323	ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2008-08-28	14	0
K081497	OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS	Arthrocare Corp.	2008-07-28	60	0
K080610	ARTHROCARE ORTHOWAND SURGICAL DEVICE	Arthrocare Corp.	2008-03-31	27	0
K080482	ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01	Arthrocare Corp.	2008-03-20	27	0
K080282	ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-	Arthrocare Corp.	2008-02-15	11	1
K072865	MODIFICATON TO: ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2007-10-23	18	0
K072089	ARTHROCARE SPINEWAND	Arthrocare Corp.	2007-08-17	18	0
K071709	ARTHROCARE SYSTEM 12000	Arthrocare Corp.	2007-08-07	46	0
K071963	MODIFICATION TO: ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2007-08-07	22	0
K071374	OPUS TWINLOCK KNOTLESS FIXATION DEVICE	Arthrocare Corp.	2007-08-02	78	0
K063172	ARTHROCARE CAVITY SPINEWAND	Arthrocare Corp.	2007-04-27	191	1
K070374	ARTHROCARE ENT PLASMA WAND	Arthrocare Corp.	2007-04-25	76	1
K070958	MODIFICATION TO ARTHROCARE ARTHROWANDS	Arthrocare Corp.	2007-04-23	18	0
K070227	OPUS MAGNUM PI KNOTLESS FIXATION DEVICE	Arthrocare Corp.	2007-04-16	82	0
K070851	ARTHROCARE SPINEWANDS	Arthrocare Corp.	2007-04-13	16	0
K070671	OPUS SMARTSTITCH SUTURE DEVICE	Arthrocare Corp.	2007-04-06	25	2
K063538	ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PAT	Arthrocare Corp.	2006-12-01	7	0
K062244	OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR	Arthrocare Corp.	2006-10-02	60	0
K061349	OPUS LABRALOCK P KNOTLESS FIXATION DEVICE	Arthrocare Corp.	2006-07-14	60	0
K060425	PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA	Arthrocare Corp.	2006-07-12	145	0
K061259	MODIFICATION TO ARTHROCARE PERC-D SPINEWAND	Arthrocare Corp.	2006-05-18	13	0
K060823	ARTHROCARE WANDS	Arthrocare Corp.	2006-04-10	14	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