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

Acu Med, Inc. · Predicate Candidate Screening

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

140 daysmedian FDA review time

332 days90th percentile

48clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021321	WRIST FUSION PLATE	Acu Med, Inc.	2002-07-17	83	0
K013616	POLARUS CAP SCREW	Acu Med, Inc.	2001-12-19	44	0
K012655	CONGRUENT BONE PLATE SYSTEM	Acu Med, Inc.	2001-11-07	86	16
K992525	ACUMED MODULAR SHOULDER SYSTEM	Acu Med, Inc.	2000-02-04	191	1
K993657	ACUMED SUTURE ANCHOR	Acu Med, Inc.	2000-01-13	77	0
K980103	ACUMED SUTURE ANCHOR	Acu Med, Inc.	1998-03-16	63	0
K965028	ACUMED SUTURE WASHER	Acu Med, Inc.	1997-03-17	90	0
K965029	STABLELOC II EXTERNAL FIXATOR	Acu Med, Inc.	1997-02-19	64	1
K964500	ACUMED TENSION BAND PIN	Acu Med, Inc.	1996-12-09	31	1
K963026	TBD	Acu Med, Inc.	1996-10-28	84	0
K963118	EXTREMITY BONE SCREW	Acu Med, Inc.	1996-10-10	59	0
K963077	TBD	Acu Med, Inc.	1996-10-01	54	0
K962091	POLARUS AF ROD	Acu Med, Inc.	1996-07-24	56	0
K960769	ACUPUNCTURE NEEDLE PACK	Acu-Med, Inc.	1996-07-10	135	0
K960711	ACUMED BONE GRAFT SYSTEM	Acu Med, Inc.	1996-05-07	76	2
K960651	CERCLAGE WIRE CRIMP BLOCK	Acu-Med, Inc.	1996-05-03	78	0
K954148	SUTURE WASHER	Acu Med, Inc.	1996-01-17	134	0
K952330	EXTERNAL FIXATOR	Acu Med, Inc.	1995-10-05	140	0
K951740	INTRAMEDULARY FIXATION ROD	Acu Med, Inc.	1995-08-11	140	1
K950864	GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COA	Acu Med, Inc.	1995-07-31	154	0
K952534	TENTATIVELY POLARUS EX ROD	Acu-Med, Inc.	1995-07-13	42	0
K943855	BONE FIXATION NAIL	Acu Med, Inc.	1995-07-12	338	0
K951673	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Acu Med, Inc.	1995-07-06	86	0
K943856	FIXATION PINS/WIRES	Acu Med, Inc.	1995-07-06	332	0
K944330	ACUTRAK PLUS FIXATION SYSTEM	Acu Med, Inc.	1995-05-05	241	0
K942359	BONE PLATE SYSTEM	Acu Med, Inc.	1995-04-13	331	0
K945027	TROCHANTER MESH	Acu Med, Inc.	1995-02-01	111	0
K943857	EXTERNAL FIXATOR	Acu Med, Inc.	1995-01-27	172	0
K943782	BONE SCREW WASHER	Acu Med, Inc.	1994-12-20	139	0
K942787	BONE ANCHOR	Acu Med, Inc.	1994-12-15	185	0
K942341	CANNULATED CANCELLOUS BONE SCREW	Acu Med, Inc.	1994-12-05	203	1
K942340	CORTICAL BONE SCREW	Acu Med, Inc.	1994-12-05	203	3
K942603	ORTHOPAEDIC WIRES	Acu Med, Inc.	1994-11-09	161	0
K932099	ACUMED FLEXIBLE CANNULA	Acu Med, Inc.	1994-06-28	421	0
K933638	ACUMED CARPAL TUNNEL RELEASE KIT	Acu Med, Inc.	1994-03-24	240	0
K932027	OREGON FIXATION SYSTEM INTERFERENCE SCREW	Acu Med, Inc.	1994-02-23	303	0
K933361	ACUMED RADIUS ROD	Acu Med, Inc.	1994-02-22	228	0
K931246	CERCLAGE WIRE CRIMP SLEEVE	Acu Med, Inc.	1994-02-22	348	0
K931244	BONE PLATE	Acu Med, Inc.	1994-02-15	341	1
K930834	ACUTRACT	Acu Med, Inc.	1993-07-26	159	0
K920666	INTRAMEDULARY FIXATION ROD	Acu Med, Inc.	1992-08-05	174	0
K921480	OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM	Acu-Med, Inc.	1992-06-26	88	1
K920667	GREAT TOE IMPLANT	Acu Med, Inc.	1992-06-19	127	0
K915613	BONE SCREW 3.5 MM	Acu Med, Inc.	1992-02-13	59	0
K910976	OREGON FIXATION SCREW	Acu Med, Inc.	1992-01-13	312	0
K910193	HUENE FIXATION SCREW	Acu-Med, Inc.	1991-08-23	219	0
K910186	WYMAN SUTURE WASHER	Acu Med, Inc.	1991-07-25	191	0
K904383	ACUFIT TOTAL HIP	Acu Med, Inc.	1990-12-20	85	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