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

Stelkast Company · Predicate Candidate Screening

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

81 daysmedian FDA review time

203 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122883	EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GE	Stelkast Company	2013-08-05	319	1
K122773	CROSS-OVER ACETABULAR SHELL & LINER	Stelkast Company	2012-10-09	29	1
K094035	EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343	Stelkast Company	2011-03-24	449	0
K081458	PROVEN STEM EXTENDER	Stelkast Company	2008-06-06	14	0
K063211	PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT	Stelkast Company	2007-01-18	87	0
K051976	PROVEN REVISION MODULAR TIBIAL TRAY	Stelkast Company	2005-10-17	88	5
K033944	STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD	Stelkast Company	2004-03-12	84	0
K032824	STELKAST UNICONDYLAR KNEE SYSTEM	Stelkast Company	2003-11-13	64	1
K031901	PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT	Stelkast Company	2003-10-10	112	0
K032110	PROCLASS PRESS FIT HIP STEM	Stelkast Company	2003-09-22	75	0
K030577	PROVEN MODULAR TIBIAL TRAY	Stelkast Company	2003-03-25	29	0
K021908	PROVEN MODULAR POSTERIOR STABILIZED FEMORAL	Stelkast Company	2002-07-09	29	1
K014049	EPOCA CODR STEM AND HEAD	Stelkast Company	2002-01-09	30	0
K010282	LATERAL OFFSET PROTRACT PRESS FIT HIP STEM	Stelkast Company	2001-02-09	10	0
K010241	PROTRACT PRESS FIT HIP STEM-HA COATED	Stelkast Company	2001-02-08	14	0
K003447	PROTRACT PRESS FIT HIP STEM	Stelkast Company	2000-12-15	39	0
K002796	MODIFICATION TO PROVIDENT HIP SYSTEM	Stelkast Company	2000-09-28	21	0
K001984	PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT	Stelkast Company	2000-09-27	90	0
K002281	STELKAST PROVEN KNEE SYSTEM	Stelkast Company	2000-08-17	24	1
K001745	MODIFICATION TO PROVIDENT HIP SYSTEM	Stelkast Company	2000-07-27	49	0
K000113	PROVEN KNEE SYSTEM	Stelkast Company	2000-04-04	81	0
K991622	26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER	Stelkast Company	1999-07-14	64	0
K981451	ARGOMEDICAL BIPOLAR SYSTEM	Stelkast Company	1998-08-21	121	0
K980276	STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM	Stelkast Company	1998-04-24	88	1
K972961	STELKAST BIPOLAR SYSTEM	Stelkast Company	1997-11-04	85	0
K970490	PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT	Stelkast Company	1997-05-02	81	0
K970194	PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT	Stelkast Company	1997-04-14	83	0
K960908	SRRS PRESSED FIT FEMORAL REVISION COMPONENT	Stelkast Company	1996-08-08	156	0
K960180	22 MM COCR HEAD & POLYETHLENE LINER	Stelkast Company	1996-05-02	107	0
K953268	DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT	Stelkast Company	1996-01-17	188	2
K954466	PROFORM POROUS BEADED FEMORAL STEM	Stelkast Company	1995-12-04	70	0
K953169	STELKAST ALL POLYETHYLENE ACETABULAR CUP	Stelkast Company	1995-08-08	32	0
K952461	ENDO PROSTHESIS FEMORAL HEAD	Stelkast Company	1995-06-30	35	0
K951083	PROFORM CEMENTED FEMORAL COMPONENT	Stelkast Company	1995-05-22	74	0
K950827	PROFORM POROUS ACETABULAR ASSEMBLY	Stelkast Company	1995-04-18	54	0
K946371	PROVIDENT HP SYSTEM	Stelkast Company	1995-04-05	120	0
K936256	MODULAR CERAMIC FEMORAL HEAD	Stelkast Company	1994-11-14	319	0
K935484	PROVIDENT HIP SYSTEM	Stelkast Company	1994-06-06	203	0
K934161	PROFORM HIP SYSTEM	Stelkast Company	1994-03-10	195	0
K934162	PROFORM HA HIP SYSTEM	Stelkast Company	1994-03-09	194	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