Data / Medical devices / United States / Arthrosurface, Inc.
Arthrosurface, Inc.: FDA-registered device maker in W Bridgewater, MA, United States, 27 510(k) clearances
Arthrosurface, Inc. is registered with the FDA (registration 3004154314) in W Bridgewater, MA, United States. It lists 18 device types. The FDA files 27 510(k) clearances under its listings, the newest dated June 24, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004154314
- Address
- 319 Manley St, W Bridgewater, MA, United States, 02379
- Owner or operator
- Arthrosurface, Inc. (9058162)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- June 2, 2004
- Registered through
- 2026
- Brand names listed
- 40mm Starter Reamer, Humeral Head, AlignMATE Instruments, AlignMATE Lapidus Arthrodesis System, Arthrosurface Bone Screws, Arthrosurface® Total Toe - Proximal Phalanx Implant, BOSS Toe Fixation System, BaseCAP, Bunion Reamer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2021 | K203375 | OVOMotion Reverse Shoulder Arthroplasty System | PHX | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| October 15, 2020 | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | JWJ | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| August 14, 2019 | K190261 | BOSS Toe Fixation System | KWD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| June 14, 2018 | K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | KRR | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| April 18, 2018 | K173964 | OVOMotion Shoulder Arthroplasty System | HSD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| December 22, 2017 | K172383 | Arthrosurface Bone Screws | HWC | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| May 3, 2017 | K170440 | KISSloc Suture System | HTN | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| March 3, 2017 | K170350 | ToeMATE® Hammertoe Correction System | HWC | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| February 21, 2017 | K162391 | AlignMATE Lapidus Arthrodesis System | HRS | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| June 30, 2016 | K161539 | Arthrosurface Bone Screws | HWC | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| April 11, 2016 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | KWD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| December 23, 2014 | K141920 | Wrist Hemiarthroplasty System | KWN | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | HSD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| July 3, 2014 | K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | HTN | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| February 26, 2014 | K132496 | ARTHROSURFACE TOEMOTION | LZJ | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| November 19, 2013 | K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | KWD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| July 25, 2013 | K130859 | HAMMERTOE CORRECTION SYSTEM | HWC | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| November 28, 2012 | K122334 | CHECKMATE SMALL BONE FUSION SYSTEM | HRS | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| February 6, 2012 | K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM | HRS | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| October 27, 2009 | K091196 | GRS GLENOID RESURFACING SYSTEM | KWS | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| November 9, 2007 | K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | KRR | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| January 12, 2007 | K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | KWD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| March 16, 2006 | K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | KRR | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| October 11, 2005 | K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | HSX | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| February 18, 2004 | K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | KWD | Substantially Equivalent | Arthrosurface, Inc. | accessdata.fda.gov |
| April 10, 2003 | K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | HSD | Substantially Equivalent | Std Mfg., Inc. | accessdata.fda.gov |
| August 1, 2002 | K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | KXA | Substantially Equivalent | Std Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2014 | 69723 | Class II | Terminated | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis componen | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | accessdata.fda.gov |
| June 9, 2014 | 72695 | Class II | Terminated | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001). | An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Toe, Hemi-, Phalangeal
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Wrist, Carpal Scaphoid
- All makers of Prosthesis, Wrist, Carpal Lunate
Updated June 24, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.