Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LZJ — Predicate Candidate Screening

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

201 daysmedian FDA review time

471 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K132496	ARTHROSURFACE TOEMOTION	Arthrosurface, Inc.	2014-02-26	201	1
K102549	THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY	Ascension Orthopedics, Inc.	2010-12-21	105	0
K072251	MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM	Merete Medical GmbH	2008-05-08	269	0
K950864	GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COA	Acu Med, Inc.	1995-07-31	154	0
K941650	TOTAL TOE SYSTEM II	Biomet, Inc.	1994-12-19	258	0
K924724	KINETIK GREAT TOE SYSTEM	Kinetikos Medical, Inc.	1994-01-05	471	0
K922211	OSTEOMED GREAT TOE SYSTEM	Osteomed Corp.	1993-11-09	546	0
K920446	TOTAL TOE SYSTEM	Biomet, Inc.	1993-03-22	412	0
K920667	GREAT TOE IMPLANT	Acu Med, Inc.	1992-06-19	127	0
K911552	ANATOMIC TOE SYSTEM	Orthopaedic Biosystems	1991-06-28	81	0
K884561	KOENIG TOTAL TOE IMPLANT	Dow Corning Wright	1989-01-24	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