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

Ace Medical Co. — Predicate Candidate Screening

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

83 daysmedian FDA review time

172 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972183	DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL	Ace Medical Co.	1997-08-26	77	2
K955472	ACE HUMERUS & RADIUS PLATES	Ace Medical Co.	1996-04-01	123	0
K955388	ACE-DUPONT COMPOSITE RINGS	Ace Medical Co.	1996-01-31	68	0
K954485	6.5MM SOLID CANCELLOUS BONE SCREW	Ace Medical Co.	1995-10-31	34	0
K954069	ACE CERVICAL TRACTION HALOZS, TONGS & PINS	Ace Medical Co.	1995-10-12	43	0
K950618	ACE SUPRACONDYLAR PLATE	Ace Medical Co.	1995-05-10	89	0
K933968	ACE PELVIC STABILIZER	Ace Medical Co.	1994-06-16	304	0
K931652	ACE 6.5 MM BONE SCREW	Ace Medical Co.	1994-04-28	388	0
K930592	ACE UNIVERSAL RECONSTRUCTION PLATE	Ace Medical Co.	1993-07-26	172	0
K912598	ACE CORTICAL BONE SCREW	Ace Medical Co.	1991-11-27	170	0
K914858	ACE OPEN-BACK HALO RING	Ace Medical Co.	1991-11-21	23	0
K911554	AIM TIBIAL NAIL	Ace Medical Co.	1991-07-08	90	0
K905595	ACE RECONSTRUCTIVE PLATE	Ace Medical Co.	1991-03-14	91	0
K905048	ACE 3.5MM CORTICAL BONE SCREW	Ace Medical Co.	1991-01-30	83	0
K903811	ACE CANNULATED CORTICAL BONE SCREW	Ace Medical Co.	1990-10-16	57	0
K903810	ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW	Ace Medical Co.	1990-10-16	57	0
K892214	REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW	Ace Medical Co.	1989-06-22	80	0
K873684	ACE INTRA COMPARTMENTAL PRESSURE MONITOR	Ace Medical Co.	1988-01-20	128	0
K874593	ACE SELFTAPPING CANCELLOUS BONE SCREW	Ace Medical Co.	1987-11-24	15	0
K872858	WILLIAMS VERTEBRAL SPREADER	Ace Medical Co.	1987-10-15	86	0
K872859	ACE CANCELLOUS BONE SCREW	Ace Medical Co.	1987-08-17	27	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