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

Ace Orthopedic Manufacturing Co. · Predicate Candidate Screening

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

57 daysmedian FDA review time

159 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K934962	AIM SUPRACONDYLAR NAIL	Ace Orthopedic Manufacturing Co.	1994-03-22	155
K934643	ACE HUMERAL NAIL	Ace Orthopedic Manufacturing Co.	1994-03-22	174
K936045	ACE UNILATERAL FIXATOR II	Ace Orthopedic Manufacturing Co.	1994-02-22	64
K926047	ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW	Ace Orthopedic Manufacturing Co.	1993-03-31	120
K920738	ACE 100 DEGREES TUBULAR PLATE	Ace Orthopedic Manufacturing Co.	1992-07-27	159
K813554	ACE/KYLE CAPTURED HIP SCREW	Ace Orthopedic Manufacturing Co.	1982-01-12	21
K810193	TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG	Ace Orthopedic Manufacturing Co.	1981-03-20	56
K801594	ACE FISCHER EXTERNAL FIXATION DEVICE	Ace Orthopedic Manufacturing Co.	1980-09-09	57
K791466	ACE EXTERNAL BONE CLAMP PART #S11	Ace Orthopedic Manufacturing Co.	1979-08-16	15
K781840	EXTERNAL ARTICULATION	Ace Orthopedic Manufacturing Co.	1978-11-08	12
K781839	BONE CLAMP, ACE EXTERNAL	Ace Orthopedic Manufacturing Co.	1978-11-08	12
K781841	BAR, DISTRACTION	Ace Orthopedic Manufacturing Co.	1978-11-08	12
K781251	THREADED PIN, SELF DRILLING	Ace Orthopedic Manufacturing Co.	1978-08-31	41
K761229	ANAL/RECTAL SYRINGE	Ace Orthopedic Manufacturing Co.	1977-02-24	76

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