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

KWH — Predicate Candidate Screening

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

88 daysmedian FDA review time

265 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K191966	NewPrim System	Brm Extremities	2020-02-13	205	0
K190136	Fusion Silastic System	Fusion Orthopedics, LLC	2019-10-21	265	0
K173491	RTS Lesser MTP Implant System	In2bones USA, LLC	2018-02-23	102	0
K153609	RTS Flexible 1 MPJ Implant w/Grommets	In2bones USA, LLC	2016-09-08	266	0
K102601	ORTHOFLEX ROD	Ortho-Pro, LLC	2011-01-14	127	0
K023531	LESSER METATARSAL PHALANGEAL JOINT IMPLANT	Nexa Orthopedics, Inc.	2003-01-17	88	1
K022887	INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM	Osteomed Corp.	2002-11-26	88	0
K022886	METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM	Osteomed Corp.	2002-11-25	87	0
K023562	MODIFICATION TO CLASSIC GREAT TOE IMPLANT	Nexa Orthopedics, Inc.	2002-11-13	21	0
K023086	CLASSIC GREAT TOE IMPLANT	Nexa Orthopedics, Inc.	2002-10-04	17	0
K994326	ASCENT KNEE SYSTEM	Biomet Manufacturing, Inc.	2000-01-07	16	0
K981194	FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT	Nexa Orthopedics, Inc.	1998-06-30	89	0
K946236	PROFIX CONFORMING PLUS TIBIAL INSERT	Smith & Nephew Richards, Inc.	1995-07-06	196	0
K943354	SUTTER HAMMERTOE JOINT PROSTHESIS	Sutter Corp.	1995-06-12	335	0
K905795	SGARLATO FLEXIBLE HINGE TOE IMPLANT	Sgarlato Laboratories, Inc.	1991-05-29	153	1
K884739	SGARLATO LESSER TOE IMPLANT	Sgarlato Laboratories, Inc.	1989-05-18	185	0
K823405	ZIMMER GREAT TOE	Zimmer, Inc.	1983-01-24	70	0
K820813	LESSER METATARSAL PHALANG. JOINT PROSTH	Sutter Biomedical, Inc.	1982-05-21	59	0
K801345	KAMPNER HINGED TOE PROSTHESIS	Biomedics	1980-07-08	32	0
K801094	SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL	Dow Corning Corp. Healthcare Industries Materials	1980-06-09	32	0
K780132	IMPLANT, HINGE TOE, FLEX.	Dow Corning Corp. Healthcare Industries Materials	1978-02-06	13	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