Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004154314

FEI Number

3004154314

Entity Name

ARTHROSURFACE, INC.

City/State/Country

W Bridgewater, MA, US

Establishment Address

319 Manley St, W Bridgewater, MA 02379, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Arthrosurface, Inc. (Owner Number: 9058162)

Owner / Operator Contact Address

319 Manley St, --, W Bridgewater, MA 02379, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141920

PMA Number

N/A

All Registered Proprietary Names

KISSLocTM Suture System Bunion Reamer 40mm Starter Reamer, Humeral Head OVOMotion Reverse Shoulder Arthroplasty System RevoMotion Reverse Total Shoulder Arthroplasty System OVOMotion Shoulder Arthroplasty System HemiCAP Humeral Head Resurfacing HemiCAP® Talar Contoured Articular Prosthesis HammerToe Correction System OsteoMATE Instruments AlignMATE Instruments Glenojet Instruments SpeedSpiral Instruments SpiralUp Instrument Kits HemiCAP Instrument Kits NanoFx Microfracture Instrument BOSS Toe Fixation System HemiCAP Unicondylar Femoral Resurfacing Prosthesis Arthrosurface Bone Screws ToeMATE® Hammertoe Correction System HemiCap GRS Glenoid Resurfacing System HemiCAP 7mm MTP Resurfacing HemiCAP Femoral Head Resurfacing HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System CheckMate MTP Arthrodesis System Pinit Small Bone Fusion System HemiCAP(TM) Toe Joint Resurfacing Patello-Femoral Wave (Kahuna) Arthroplasty System HemiCAP Patello-Femoral Resurfacing HemiCAP PFXL Resurfacing System Arthrosurface® Total Toe - Proximal Phalanx Implant UniCAP Knee Resurfacing Prosthesis Wrist Hemiarthroplasty System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-10-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-01-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-10-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-07-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-07-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2007-11-20
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2017-09-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-10-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2004-06-02
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2020-02-05
HSA	Prosthesis, Knee, Hemi-, Femoral	Orthopedic	Class 3	888.3570	2017-09-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-03-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-11-21
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2007-11-20
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2007-11-20
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2015-07-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-08-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-08-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-01-09
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2007-11-20
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2018-07-26
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2006-06-28
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2009-11-16
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained	Unknown	Class U	N/A	2014-10-08
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2008-03-25
KWO	Prosthesis, Wrist, Carpal Scaphoid	Orthopedic	Class 2	888.3760	2016-01-20
KWN	Prosthesis, Wrist, Carpal Lunate	Orthopedic	Class 2	888.3750	2016-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arthrosurface, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004154314. Last updated year: 2026. Please use registration number 3004154314 when referencing this establishment in official correspondence.