Home / Companies / Arthrosurface, Inc.

Arthrosurface, Inc.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
26
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1112-2015Class IIArthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: November 24, 2014
Z-1113-2015Class IIAthrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: November 24, 2014
Z-1114-2015Class IIArthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part NuNovember 24, 2014
Z-1110-2015Class IIArthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat NumberNovember 24, 2014
Z-1111-2015Class IIArthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part NumbeNovember 24, 2014
Z-0475-2016Class IITotal Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part NumbJune 9, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K203375OVOMotion Reverse Shoulder Arthroplasty SystemJune 24, 2021
K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemOctober 15, 2020
K190261BOSS Toe Fixation SystemAugust 14, 2019
K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemJune 14, 2018
K173964OVOMotion Shoulder Arthroplasty SystemApril 18, 2018
K172383Arthrosurface Bone ScrewsDecember 22, 2017
K170440KISSloc Suture SystemMay 3, 2017
K170350ToeMATE® Hammertoe Correction SystemMarch 3, 2017
K162391AlignMATE™ Lapidus Arthrodesis SystemFebruary 21, 2017
K161539Arthrosurface Bone ScrewsJune 30, 2016
K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemApril 11, 2016
K141920Wrist Hemiarthroplasty SystemDecember 23, 2014
K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemDecember 19, 2014
K133835ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEMJuly 3, 2014
K140617PINIT SMALL BONE FUSION SYSTEMApril 25, 2014
K132496ARTHROSURFACE TOEMOTIONFebruary 26, 2014
K131377HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTNovember 19, 2013
K130859HAMMERTOE CORRECTION SYSTEMJuly 25, 2013
K122334CHECKMATE SMALL BONE FUSION SYSTEMNovember 28, 2012
K113762CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEMFebruary 6, 2012