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

Medacta International — Predicate Candidate Screening

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

96 daysmedian FDA review time

189 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160605	MectaLIF Anterior Stand-Alone	Medacta International	2016-07-21	141	0
K160289	MasterLoc Stem	Medacta International	2016-05-20	107	0
K153664	M.U.S.T. Pedicle Screw System	Medacta International	2016-01-19	29	0
K151531	MasterLoc Stem	Medacta International	2015-10-30	144	0
K142744	Mecta-C TiPEEK	Medacta International	2015-05-07	225	0
K143453	Mpact Double Mobility System	Medacta International	2015-03-02	89	0
K142069	GMK EXTENSION	Medacta International	2014-12-02	125	0
K141988	M.U.S.T PEDICLE SCREW SYSTEM	Medacta International	2014-08-19	28	0
K141044	M.U.S.T. EXTENSION	Medacta International	2014-08-18	117	0
K140826	GMK SPHERE EXTENSION	Medacta International	2014-07-15	105	0
K140361	META-C CERVICAL PLATE	Medacta International	2014-06-12	120	0
K132788	MYSPINE PEDICLE SCREW PLACEMENT GUIDES	Medacta International	2014-05-23	259	0
K133192	MECTALIF TIPEEK	Medacta International	2014-01-30	105	0
K132879	MPACT EXTENSION	Medacta International	2014-01-22	131	0
K133630	GMK SHORT STEM	Medacta International	2013-12-20	24	0
K132878	M.U.S.T. EXTENSION	Medacta International	2013-12-18	96	0
K131518	MECTACER BIOLOX OPTION HEADS	Medacta International	2013-11-04	160	0
K131458	MPACT DM LINER CONVERTER	Medacta International	2013-10-01	134	0
K131310	GMK FULL PE TIBIAL COMPONENTS	Medacta International	2013-08-22	107	0
K130299	GMK HINGE	Medacta International	2013-08-15	189	2
K123721	GMK REVISION EXTENSION	Medacta International	2013-07-26	234	0
K131671	MECTALIF	Medacta International	2013-07-05	28	0
K124034	MECTALIF ANTERIOR	Medacta International	2013-05-17	140	0
K122911	VERSAFITCUP CC TRIO EXTENSION	Medacta International	2012-10-19	28	0
K122232	GMK NARROW	Medacta International	2012-09-28	64	0
K122641	MPACT EXTENSION	Medacta International	2012-09-28	30	0
K121416	GMK SPHERE	Medacta International	2012-07-20	70	0
K121115	M.U.S.T PEDICLE SCREW SYSTEM	Medacta International	2012-07-18	97	1
K120790	GMK - LINE EXTENSION	Medacta International	2012-06-08	85	0
K121011	AMISTEM AND QUADRA - LINE EXTENSION	Medacta International	2012-06-08	66	0
K120531	VERSAFITCUP CC TRIO-ADDITIONAL LINERS	Medacta International	2012-04-18	56	0
K113571	GMK RESUFACING PATELLA SIZE 4	Medacta International	2012-01-27	56	0
K112862	MECTA-C	Medacta International	2011-12-19	80	0
K112115	MECTACER BIOLOX(R) DELTA FEMORAL HEADS	Medacta International	2011-10-07	74	0
K111145	ENDO HEAD	Medacta International	2011-08-16	116	0
K110927	MECTALIF	Medacta International	2011-06-13	77	1
K111283	GMK REVISION HYBRID LINERS	Medacta International	2011-05-27	21	0
K103721	MPACT ACETABULAR SYSTEM	Medacta International	2011-03-21	90	0
K103352	VERSAFITCUP CC TRIO	Medacta International	2011-02-11	87	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