Atlas FDA

KYI

26 FDA 510(k) clearances · Product code

88 daysmedian time to decision
331 days90th percentile
26clearances measured

FDA profile

Official device name
Prosthesis, Wrist, Carpal Trapezium
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3770
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2009: 56 · 2010: 25 · 2011: 72 · 2012: 22 · 2013: 23 · 2019: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (K201072)Ensemble Orthopedics, LLC2020-12-02
Stablyx CMC Arthroplasty Implant System (K180744)Skeletal Dynamics, LLC2018-04-11
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (K111068)Skeletal Dynamics, LLC2011-12-30
ASCENSION NUGRIP CMC IMPLANT (K112278)Ascension Orthopedic2011-11-04
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (K092548)Extremity Medical, LLC2009-12-15
ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
ARTELON CMC SPACER ARTHRO (K061954)Artimplant AB2007-06-01
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451)Ascension Orthopedics, Inc.2006-08-11
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089)Biopro, Inc.2006-06-20
NEXA CARPO METACARPAL IMPLANT (K060386)Nexa Orthopedics, Inc.2006-05-10
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (K052596)Biopro, Inc.2005-11-15
ASCENSION PYROSPHERE (PCS) (K042690)Ascension Orthopedics, Inc.2004-11-13
ARTELON SPACER CMC-1 (K040070)Artimplant AB2004-09-21
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (K041451)Ascension Orthopedics, Inc.2004-08-25
TIE-IN TRAPEZIUM (K033529)Wrightmedicaltechnologyinc2003-12-03
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT (K965204)Avanta Orthopaedics, Inc.1997-06-03
METALLIC SPHERICAL CMC IMPLANT (K960534)Wrightmedicaltechnologyinc1997-02-06
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) (K960659)Wrightmedicaltechnologyinc1997-02-06
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (K964472)Biologically Oriented Prostheses1997-02-03
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT (K964381)Avanta Orthopaedics, Inc.1997-01-22
STRICKLAND TRAPEZIAL IMPLANT (K951471)Wrightmedicaltechnologyinc1995-08-09
SWANSON TITANIUM CONDYLAR IMPLANT (K864488)Dow Corning Wright1987-04-15
SWANSON TITANIUM TRAPEZIUM IMPLANT (K864489)Dow Corning Wright1987-04-15
SPINE ALIGN (K801952)B.H. Richardson, D.C.1980-09-16
TRAPEZIO-METACARPAL JOINT SPACER (K790508)Scientific Data Systems Israel, Ltd.1979-04-10
SILASTIC H.P. TRAPEXIAL IMPLANT (K781756)Dow Corning Corp. Healthcare Industries Materials1978-11-15

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