Arthrosurface, Inc.
W Bridgewater, MA, US
ARTHROSURFACE, INC. appears in FDA device records in W Bridgewater, MA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Arthrosurface, Inc. between 2004 and 2021. The busiest year on record is 2014, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 5 |
| 2016 | 2 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | PHX | Substantially Equivalent | |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | JWJ | Substantially Equivalent | |
| K190261 | BOSS Toe Fixation System | KWD | Substantially Equivalent | |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | KRR | Substantially Equivalent | |
| K173964 | OVOMotion Shoulder Arthroplasty System | HSD | Substantially Equivalent | |
| K172383 | Arthrosurface Bone Screws | HWC | Substantially Equivalent | |
| K170440 | KISSloc Suture System | HTN | Substantially Equivalent | |
| K170350 | ToeMATE® Hammertoe Correction System | HWC | Substantially Equivalent | |
| K162391 | AlignMATE™ Lapidus Arthrodesis System | HRS | Substantially Equivalent | |
| K161539 | Arthrosurface Bone Screws | HWC | Substantially Equivalent | |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | KWD | Substantially Equivalent | |
| K141920 | Wrist Hemiarthroplasty System | KWN | Substantially Equivalent | |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | HSD | Substantially Equivalent | |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | HTN | Substantially Equivalent | |
| K140617 | PINIT SMALL BONE FUSION SYSTEM | HRS | Substantially Equivalent | |
| K132496 | ARTHROSURFACE TOEMOTION | LZJ | Substantially Equivalent | |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | KWD | Substantially Equivalent | |
| K130859 | HAMMERTOE CORRECTION SYSTEM | HWC | Substantially Equivalent | |
| K122334 | CHECKMATE SMALL BONE FUSION SYSTEM | HRS | Substantially Equivalent | |
| K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM | HRS | Substantially Equivalent | |
| K091196 | GRS GLENOID RESURFACING SYSTEM | KWS | Substantially Equivalent | |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | KRR | Substantially Equivalent | |
| K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | KWD | Substantially Equivalent | |
| K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | KRR | Substantially Equivalent | |
| K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | HSX | Substantially Equivalent | |
| K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | KWD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004154314 | 3004154314 | ARTHROSURFACE, INC. | 319 Manley St, W Bridgewater, MA 02379 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- HRSPlate, Fixation, Bone
- NTGProsthesis, Ankle, Uncemented, Non-Constrained
- KXAProsthesis, Hip, Femoral, Resurfacing
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HSAProsthesis, Knee, Hemi-, Femoral
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- KWDProsthesis, Toe, Hemi-, Phalangeal
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- KWNProsthesis, Wrist, Carpal Lunate
- KWOProsthesis, Wrist, Carpal Scaphoid
- HWCScrew, Fixation, Bone
- PHXShoulder Prosthesis, Reverse Configuration
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1114-2015 | Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Class II | Terminated | |
| Z-1113-2015 | Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Class II | Terminated | |
| Z-1112-2015 | Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Class II | Terminated | |
| Z-1111-2015 | Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Class II | Terminated | |
| Z-1110-2015 | 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 component. | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | Class II | Terminated | |
| Z-0475-2016 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain