Atlas FDA

KWH

21 FDA 510(k) clearances · Product code

88 daysmedian time to decision
265 days90th percentile
21clearances measured

FDA profile

Official device name
Prosthesis, Toe, Constrained, Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3720
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2006: 8 · 2007: 2 · 2008: 4 · 2009: 5 · 2012: 6 · 2019: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NewPrim System (K191966)Brm Extremities2020-02-13
Fusion Silastic System (K190136)Fusion Orthopedics, LLC2019-10-21
RTS Lesser MTP Implant System (K173491)In2bones USA, LLC2018-02-23
RTS Flexible 1 MPJ Implant w/Grommets (K153609)In2bones USA, LLC2016-09-08
ORTHOFLEX ROD (K102601)Ortho-Pro, LLC2011-01-14
LESSER METATARSAL PHALANGEAL JOINT IMPLANT (K023531)Nexa Orthopedics, Inc.2003-01-17
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022887)Osteomed Corp.2002-11-26
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022886)Osteomed Corp.2002-11-25
MODIFICATION TO CLASSIC GREAT TOE IMPLANT (K023562)Nexa Orthopedics, Inc.2002-11-13
CLASSIC GREAT TOE IMPLANT (K023086)Nexa Orthopedics, Inc.2002-10-04
ASCENT KNEE SYSTEM (K994326)Biomet Manufacturing, Inc.2000-01-07
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT (K981194)Nexa Orthopedics, Inc.1998-06-30
PROFIX CONFORMING PLUS TIBIAL INSERT (K946236)Smith & Nephew Richards, Inc.1995-07-06
SUTTER HAMMERTOE JOINT PROSTHESIS (K943354)Sutter Corp.1995-06-12
SGARLATO FLEXIBLE HINGE TOE IMPLANT (K905795)Sgarlato Laboratories, Inc.1991-05-29
SGARLATO LESSER TOE IMPLANT (K884739)Sgarlato Laboratories, Inc.1989-05-18
ZIMMER GREAT TOE (K823405)Zimmer, Inc.1983-01-24
LESSER METATARSAL PHALANG. JOINT PROSTH (K820813)Sutter Biomedical, Inc.1982-05-21
KAMPNER HINGED TOE PROSTHESIS (K801345)Biomedics1980-07-08
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL (K801094)Dow Corning Corp. Healthcare Industries Materials1980-06-09
IMPLANT, HINGE TOE, FLEX. (K780132)Dow Corning Corp. Healthcare Industries Materials1978-02-06

Track KWH automatically

Every clearance here is in the API, with alerts when new ones post.