Arthrosurface, Inc.
FDA Regulatory Profile
Arthrosurface, Inc. appears in FDA public data with 6 recalls, 26 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1114-2015, Class II) was initiated on November 24, 2014. Its most recent 510(k) clearance was granted on June 24, 2021.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 26
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1114-2015 | Class II | Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Nu | November 24, 2014 |
| Z-1112-2015 | Class II | Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: | November 24, 2014 |
| Z-1111-2015 | Class II | Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Numbe | November 24, 2014 |
| Z-1110-2015 | Class II | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number | November 24, 2014 |
| Z-1113-2015 | Class II | Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: | November 24, 2014 |
| Z-0475-2016 | Class II | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Numb | June 9, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | June 24, 2021 |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | October 15, 2020 |
| K190261 | BOSS Toe Fixation System | August 14, 2019 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | June 14, 2018 |
| K173964 | OVOMotion Shoulder Arthroplasty System | April 18, 2018 |
| K172383 | Arthrosurface Bone Screws | December 22, 2017 |
| K170440 | KISSloc Suture System | May 3, 2017 |
| K170350 | ToeMATE® Hammertoe Correction System | March 3, 2017 |
| K162391 | AlignMATE Lapidus Arthrodesis System | February 21, 2017 |
| K161539 | Arthrosurface Bone Screws | June 30, 2016 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | April 11, 2016 |
| K141920 | Wrist Hemiarthroplasty System | December 23, 2014 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | December 19, 2014 |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | July 3, 2014 |
| K140617 | PINIT SMALL BONE FUSION SYSTEM | April 25, 2014 |
| K132496 | ARTHROSURFACE TOEMOTION | February 26, 2014 |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | November 19, 2013 |
| K130859 | HAMMERTOE CORRECTION SYSTEM | July 25, 2013 |
| K122334 | CHECKMATE SMALL BONE FUSION SYSTEM | November 28, 2012 |
| K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM | February 6, 2012 |