Medical Device Manufacturer · US , Stoughton , MA

Arthrosurface, Inc.

26 submissions · 26 cleared · Since 2004
26
Total
26
Cleared
0
Denied

Arthrosurface, Inc. — FDA 510(k) Submissions

Arthrosurface, Inc. has submitted 26 FDA 510(k) premarket notifications since 2004, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Toe, Hemi-, Phalangeal, Plate, Fixation, Bone, Screw, Fixation, Bone, Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer, Washer, Bolt Nut . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
OVOMotion Reverse Shoulder Arthroplasty System
K203375 · PHX Shoulder Prosthesis,... · Orthopedic
Jun 2021 220d
Arthrosurface WristMotion Total Wrist Arthroplasty System
K200718 · JWJ Prosthesis, Wrist, 3 Part... · Orthopedic
Oct 2020 210d
BOSS Toe Fixation System
K190261 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Aug 2019 187d
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280 · KRR Prosthesis, Knee,... · Orthopedic
Jun 2018 30d
OVOMotion Shoulder Arthroplasty System
K173964 · HSD Prosthesis, Shoulder,... · Orthopedic
Apr 2018 110d
Arthrosurface Bone Screws
K172383 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2017 136d
KISSloc Suture System
K170440 · HTN Washer, Bolt Nut · Orthopedic
May 2017 78d
ToeMATE? Hammertoe Correction System
K170350 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2017 28d
AlignMATE? Lapidus Arthrodesis System
K162391 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2017 179d
Arthrosurface Bone Screws
K161539 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2016 27d
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Apr 2016 227d
Wrist Hemiarthroplasty System
K141920 · KWN Prosthesis, Wrist, Carpal... · Orthopedic
Dec 2014 160d
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
K142942 · HSD Prosthesis, Shoulder,... · Orthopedic
Dec 2014 66d
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
K133835 · HTN Washer, Bolt Nut · Orthopedic
Jul 2014 197d
PINIT SMALL BONE FUSION SYSTEM
K140617 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2014 45d
ARTHROSURFACE TOEMOTION
K132496 · LZJ Prosthesis, Toe... · Orthopedic
Feb 2014 201d
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Nov 2013 189d
HAMMERTOE CORRECTION SYSTEM
K130859 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2013 119d
CHECKMATE SMALL BONE FUSION SYSTEM
K122334 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2012 118d
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2012 47d
GRS GLENOID RESURFACING SYSTEM
K091196 · KWS Prosthesis, Shoulder,... · Orthopedic
Oct 2009 187d
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
K071413 · KRR Prosthesis, Knee,... · Orthopedic
Nov 2007 172d
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
K063370 · KWD Prosthesis, Toe, Hemi-,... · Orthopedic
Jan 2007 65d
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
K060127 · KRR Prosthesis, Knee,... · Orthopedic
Mar 2006 57d
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
K050373 · HSX Prosthesis, Knee,... · Orthopedic
Oct 2005 239d
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