Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arthrosurface, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
160 daysmedian FDA review time
227 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | 2021-06-24 | 220 | 0 |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | 2020-10-15 | 210 | 0 |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | 2019-08-14 | 187 | 0 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | 2018-06-14 | 30 | 3 |
| K173964 | OVOMotion Shoulder Arthroplasty System | Arthrosurface, Inc. | 2018-04-18 | 110 | 0 |
| K172383 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2017-12-22 | 136 | 0 |
| K170440 | KISSloc Suture System | Arthrosurface, Inc. | 2017-05-03 | 78 | 0 |
| K170350 | ToeMATE® Hammertoe Correction System | Arthrosurface, Inc. | 2017-03-03 | 28 | 0 |
| K162391 | AlignMATE™ Lapidus Arthrodesis System | Arthrosurface, Inc. | 2017-02-21 | 179 | 0 |
| K161539 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2016-06-30 | 27 | 0 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016-04-11 | 227 | 0 |
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014-12-23 | 160 | 0 |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | Arthrosurface, Inc. | 2014-12-19 | 66 | 0 |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | Arthrosurface, Inc. | 2014-07-03 | 197 | 0 |
| K140617 | PINIT SMALL BONE FUSION SYSTEM | Arthrosurface, Inc. | 2014-04-25 | 45 | 0 |
| K132496 | ARTHROSURFACE TOEMOTION | Arthrosurface, Inc. | 2014-02-26 | 201 | 1 |
| K131377 | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2013-11-19 | 189 | 0 |
| K130859 | HAMMERTOE CORRECTION SYSTEM | Arthrosurface, Inc. | 2013-07-25 | 119 | 0 |
| K122334 | CHECKMATE SMALL BONE FUSION SYSTEM | Arthrosurface, Inc. | 2012-11-28 | 118 | 0 |
| K113762 | CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM | Arthrosurface, Inc. | 2012-02-06 | 47 | 0 |
| K091196 | GRS GLENOID RESURFACING SYSTEM | Arthrosurface, Inc. | 2009-10-27 | 187 | 0 |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | Arthrosurface, Inc. | 2007-11-09 | 172 | 0 |
| K063370 | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY | Arthrosurface, Inc. | 2007-01-12 | 65 | 0 |
| K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2006-03-16 | 57 | 0 |
| K050373 | UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2005-10-11 | 239 | 0 |
| K031859 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | 2004-02-18 | 247 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda