Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Depuy Ace Medical Co. · Predicate Candidate Screening

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

56 daysmedian FDA review time

191 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K990392	DEPUY ACE SPIDER PLATE	Depuy Ace Medical Co.	1999-03-23	42
K990120	MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE	Depuy Ace Medical Co.	1999-02-01	19
K984458	DEPUY ACE SPIDER PLATE	Depuy Ace Medical Co.	1998-12-31	16
K983853	DEPUY ACE TIMAX META PLATE	Depuy Ace Medical Co.	1998-12-22	53
K983265	DEPUY ACE COMPOSITE LOCKING NUT	Depuy Ace Medical Co.	1998-10-26	39
K982347	DEPUY ACE TIMAX PILON PLATE	Depuy Ace Medical Co.	1998-08-31	56
K981775	DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE	Depuy Ace Medical Co.	1998-07-29	70
K974245	DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG	Depuy Ace Medical Co.	1998-05-22	191
K970503	DEPUY ACE TROCHANTERIC SIDE PLATE	Depuy Ace Medical Co.	1997-04-30	79
K970202	DEPUY ACE AIM TITANIUM TIBIAL NAIL	Depuy Ace Medical Co.	1997-03-21	59

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