Company · US
Arthrosurface, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2021. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 7 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 5 |
| HRS | Plate, Fixation, Bone | 4 |
| HWC | Screw, Fixation, Bone | 4 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 3 |
| HTN | Washer, Bolt Nut | 2 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 |
| KWN | Prosthesis, Wrist, Carpal Lunate | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2021 | K203375 | OVOMotion Reverse Shoulder Arthroplasty System Arthrosurface, Inc. | PHX |
| Oct 15, 2020 | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System Arthrosurface, Inc. | JWJ |
| Aug 14, 2019 | K190261 | BOSS Toe Fixation System Arthrosurface, Inc. | KWD |
| Jun 14, 2018 | K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc. | KRR |
| Apr 18, 2018 | K173964 | OVOMotion Shoulder Arthroplasty System Arthrosurface, Inc. | HSD |
| Dec 22, 2017 | K172383 | Arthrosurface Bone Screws Arthrosurface, Inc. | HWC |
| May 3, 2017 | K170440 | KISSloc Suture System Arthrosurface, Inc. | HTN |
| Mar 3, 2017 | K170350 | ToeMATE® Hammertoe Correction System Arthrosurface, Inc. | HWC |
| Feb 21, 2017 | K162391 | AlignMATE Lapidus Arthrodesis System Arthrosurface, Inc. | HRS |
| Jun 30, 2016 | K161539 | Arthrosurface Bone Screws Arthrosurface, Inc. | HWC |
| Apr 11, 2016 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System Arthrosurface, Inc. | KWD |
| Dec 23, 2014 | K141920 | Wrist Hemiarthroplasty System Arthrosurface, Inc. | KWN |
| Dec 19, 2014 | K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System Arthrosurface, Inc. | HSD |
| Jul 3, 2014 | K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM Arthrosurface, Inc. | HTN |
| Apr 25, 2014 | K140617 | PINIT SMALL BONE FUSION SYSTEM Arthrosurface, Inc. | HRS |
| Feb 26, 2014 | K132496 | ARTHROSURFACE TOEMOTION Arthrosurface, Inc. | LZJ |
| Nov 19, 2013 | K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. | KWD |
| Jul 25, 2013 | K130859 | HAMMERTOE CORRECTION SYSTEM Arthrosurface, Inc. | HWC |
| Nov 28, 2012 | K122334 | CHECKMATE SMALL BONE FUSION SYSTEM Arthrosurface, Inc. | HRS |
| Feb 6, 2012 | K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM Arthrosurface, Inc. | HRS |
| Oct 27, 2009 | K091196 | GRS GLENOID RESURFACING SYSTEM Arthrosurface, Inc. | KWS |
| Nov 9, 2007 | K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM Arthrosurface, Inc. | KRR |
| Jan 12, 2007 | K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY Arthrosurface, Inc. | KWD |
| Mar 16, 2006 | K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS Arthrosurface, Inc. | KRR |
| Oct 11, 2005 | K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS Arthrosurface, Inc. | HSX |
| Feb 18, 2004 | K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. | KWD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2015 | Arthrosurface, Inc. 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). Terminated |
LZJ | K132496 |
| Feb 12, 2015 | Arthrosurface, Inc. 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 sh Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. 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 should Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. 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 shoulde Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. 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 shou Terminated |
HSD | K023096 |
| Feb 12, 2015 | Arthrosurface, Inc. 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 shoul Terminated |
HSD | K023096 |