ARTHROSURFACE, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004154314	3004154314	ARTHROSURFACE, INC.	1	N	2026-01-01	319 Manley St W Bridgewater MA US 02379

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
62438	1281641631	K203375	OVOMotion Reverse Shoulder Arthroplasty System	PHX	2021-06-24
62438	2063357824	K200718	Arthrosurface WristMotion Total Wrist Arthroplasty System	JWJ	2020-10-15
62438	1916007224	K190261	BOSS Toe Fixation System	KWD	2019-08-14
62438	1358206493	K181280	Patello-Femoral Wave (Kahuna) Arthroplasty System	KRR	2018-06-14
62438	1732493656	K173964	OVOMotion Shoulder Arthroplasty System	HSD	2018-04-18
62438	1072363484	K172383	Arthrosurface Bone Screws	HWC	2017-12-22
62438	1944943813	K170440	KISSloc Suture System	HTN	2017-05-03
62438	1746814128	K170350	ToeMATE® Hammertoe Correction System	HWC	2017-03-03
62438	1971392958	K162391	AlignMATE™ Lapidus Arthrodesis System	HRS	2017-02-21
62438	1664773260	K161539	Arthrosurface Bone Screws	HWC	2016-06-30
62438	1926290046	K152454	HemiCAP MTP Resurfacing Hemi-Arthroplasty System	KWD	2016-04-11
62438	1854407681	K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System	HSD	2014-12-19
62438	1197023913	K141920	Wrist Hemiarthroplasty System	KWN	2014-12-23
62438	1752839484	K133835	ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM	HTN	2014-07-03
62438	1197983761	K132496	ARTHROSURFACE TOEMOTION	LZJ	2014-02-26
62438	1864395447	K131377	HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT	KWD	2013-11-19
62438	1208516017	K130859	HAMMERTOE CORRECTION SYSTEM	HWC	2013-07-25
62438	1455005349	K122334	CHECKMATE SMALL BONE FUSION SYSTEM	HRS	2012-11-28
62438	1438899635	K113762	CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM	HRS	2012-02-06
62438	1521090625	K091196	GRS GLENOID RESURFACING SYSTEM	KWS	2009-10-27
62438	1773449111	K071413	HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM	KRR	2007-11-09
62438	1837036021	K063370	CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY	KWD	2007-01-12
62438	1453373145	K060127	HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS	KRR	2006-03-16
62438	1170544478	K050373	UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS	HSX	2005-10-11
62438	1955043062	K031859	CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT	KWD	2004-02-18
62438	1707579544	K023096	CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM	HSD	2003-04-10
62438	1003175735	K021549	CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM	KXA	2002-08-01
62438	1873253687
62438	1204771493
62438	1626689195
62438	1866083271
62438	1971041457

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KWD	5	2019-08-14
HWC	4	2017-12-22
KRR	3	2018-06-14
HSD	3	2018-04-18
HRS	3	2017-02-21
HTN	2	2017-05-03
PHX	1	2021-06-24
JWJ	1	2020-10-15
KWN	1	2014-12-23
LZJ	1	2014-02-26
KWS	1	2009-10-27
HSX	1	2005-10-11
KXA	1	2002-08-01

PMN#

Arthrosurface WristMotion Total Wrist Arthroplasty System
2020-10-15
Arthrosurface, Inc.
BOSS Toe Fixation System
2019-08-14
Arthrosurface, Inc.
Patello-Femoral Wave (Kahuna) Arthroplasty System
2018-06-14
Arthrosurface, Inc.
OVOMotion Shoulder Arthroplasty System
2018-04-18
Arthrosurface, Inc.
Arthrosurface Bone Screws
2017-12-22
Arthrosurface, Inc.
ToeMATE® Hammertoe Correction System
2017-03-03
Arthrosurface, Inc.
AlignMATE™ Lapidus Arthrodesis System
2017-02-21
ARTHROSURFACE, INC.
Arthrosurface Bone Screws
2016-06-30
ARTHROSURFACE, INC.
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
2016-04-11
ARTHROSURFACE, INC.
Wrist Hemiarthroplasty System
2014-12-23
ARTHROSURFACE, INC.
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
2014-07-03
ARTHROSURFACE, INC.
PINIT SMALL BONE FUSION SYSTEM
2014-04-25
ARTHROSURFACE, INC.
ARTHROSURFACE TOEMOTION
2014-02-26
ARTHROSURFACE, INC.
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
2013-11-19
ARTHROSURFACE, INC.
HAMMERTOE CORRECTION SYSTEM
2013-07-25
ARTHROSURFACE, INC.
CHECKMATE SMALL BONE FUSION SYSTEM
2012-11-28
ARTHROSURFACE, INC.
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
2012-02-06
ARTHROSURFACE, INC.
GRS GLENOID RESURFACING SYSTEM
2009-10-27
ARTHROSURFACE, INC.
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
2007-11-09
ARTHROSURFACE, INC.
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
2007-01-12
ARTHROSURFACE, INC.
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
2006-03-16
ARTHROSURFACE, INC.
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
2005-10-11
ARTHROSURFACE, INC.
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
2004-02-18
ARTHROSURFACE, INC.