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

Conmed Linvatec — Predicate Candidate Screening

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

89 daysmedian FDA review time

193 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111779	Y-KNOT ALL-SUTURE ANCHOR MODEL HF13	Conmed Linvatec	2011-08-08	45	0
K102410	MATRYX INTERFERENCE SCREW (5.0-6.5MM)	Conmed Linvatec	2010-12-21	119	0
K102339	CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE	Conmed Linvatec	2010-11-23	97	0
K101100	CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502,	Conmed Linvatec	2010-08-26	128	1
K092898	CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SU	Conmed Linvatec	2009-10-19	28	0
K090560	CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS	Conmed Linvatec	2009-06-29	119	0
K083161	ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADA	Conmed Linvatec	2009-03-27	151	0
K080531	CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY	Conmed Linvatec	2008-09-05	192	0
K072291	CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR	Conmed Linvatec	2008-07-14	333	0
K080444	CONMED LINVATEC OSPREY DRILL SYSTEM	Conmed Linvatec	2008-04-02	43	0
K073481	THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES	Conmed Linvatec	2008-01-07	27	0
K072706	MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MIC	Conmed Linvatec	2007-10-24	30	0
K070780	CONMED LINVATEC XO BUTTON	Conmed Linvatec	2007-08-21	153	0
K070376	CONMED LINVATEC 300W XENON LIGHT SOURCE	Conmed Linvatec	2007-08-20	193	2
K070233	CONMED LINVATEC SMART GUARD IRRIGATOR	Conmed Linvatec	2007-04-02	67	0
K063326	CONMED LINVATEC 24K IRRIGATION SYSTEM	Conmed Linvatec	2007-01-31	89	0
K063457	TRUEHD (1080P) DIGITAL CAMERA SYSTEM	Conmed Linvatec	2006-12-05	20	0
K052992	CONMED LINVATEC INSTRUMENT STERILIZATION TRAY	Conmed Linvatec	2006-10-16	356	0
K060714	HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR	Conmed Linvatec	2006-04-06	20	0
K053561	BIO-MINI REVO SUTURE ANCHOR	Conmed Linvatec	2006-02-23	64	0
K050923	LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGR	Conmed Linvatec	2005-05-18	35	1

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