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

HWT — Predicate Candidate Screening

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

28 daysmedian FDA review time

399 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K974406	ORTHOPLAN	Ortho-Graphics, Inc.	1998-02-18	89
K960685	ORTHODOC PREOPERATIVE PLANNER MODEL 500	Integrated Surgical Systems, Inc.	1997-01-17	332
K894228	KRONNER SPHERICAL CUTTERS	Kronner Medical	1990-07-23	399
K870843	SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA	Warsaw Orthopedic, Inc.	1987-05-27	85
K871323	ARTHROSCOPIC MENISCAL SUTURE SYSTEM	Orthopedic Systems, Inc.	1987-05-01	28
K830360	3M OSTEOTOMY GUIDE	3M Company	1983-03-01	26
K811205	MOLDED POLYSULFONE TRIAL PROSTHESIS	Shannon Group	1981-05-21	20
K781091	KNEE INSTRUMENTATION, CONDYLAR	Biomet, Inc.	1978-07-17	14
K771709	WORRELL TRIAL PATELLA	Depuy, Inc.	1977-10-06	24
K771710	WORRELL PATELLA TEMPLATE	Depuy, Inc.	1977-10-06	24

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