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

JDZ — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

62 daysmedian FDA review time

241 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K934253	EXACTECH ALL POLY ACETABULAR CUP	Exactech, Inc.	1994-04-29	241	0
K925025	PRISM BONE CEMENT MIXING SYSTEM	Depuy, Inc.	1994-01-05	460	0
K912190	STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST	Stryker Corp.	1991-08-29	104	2
K892937	REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS	Dentsply Intl.	1989-06-22	62	0
K861086	ZIMMER VACUUM MIXING SYSTEM	Zimmer, Inc.	1986-04-14	24	0
K854077	MIX EVAC II	Stryker Corp.	1986-01-31	116	0
K853310	SIMPLEX ENHANCEMENT MIXER	Howmedica Corp.	1985-09-11	35	0
K851205	CEMENTRIFUGE	Biodynamic Technologies, Inc.	1985-07-16	112	0
K843219	ZIMMER BONE CEMENT CENTRIFUGATION SYS	Zimmer, Inc.	1984-11-29	106	0
K792186	HOWMEDICA MIX-KIT II	Howmedica Corp.	1979-12-05	35	0
K780857	MIXING BOWL & SPATULA, DISPOSABLE	Howmedica Corp.	1978-06-13	20	0
K760636	ORTHOMIX	Diemolding Corp.	1976-10-05	22	0
K760617	MIX EVAC BONE CEMENT	Stryker Corp.	1976-10-05	22	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