Arthrosurface, Inc.: FDA clearances and approvals
Arthrosurface, Inc. has 26 FDA 510(k) clearances (first 2004, latest 2021), across 12 product codes in 1 review panel. Median 510(k) review time: 148 days. Since 2017 its median was 136 days, against 103 days for all cleared 510(k)s in the same product codes. openFDA lists 6 product recalls by a recalling firm named Arthrosurface, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 82 |
| 2013 | 2 | 154 |
| 2014 | 5 | 160 |
| 2015 | 0 | — |
| 2016 | 2 | 127 |
| 2017 | 4 | 107 |
| 2018 | 2 | 70 |
| 2019 | 1 | 187 |
| 2020 | 1 | 210 |
| 2021 | 1 | 220 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Arthrosurface, Inc.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 5 | 5 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 2 |
| HTN | Washer, Bolt Nut | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
| KWN | Prosthesis, Wrist, Carpal Lunate | 1 | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (26)
Most recent Arthrosurface, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | PHX | 2021-06-24 | 220 |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | JWJ | 2020-10-15 | 210 |
| K190261 | BOSS Toe Fixation System | KWD | 2019-08-14 | 187 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | KRR | 2018-06-14 | 30 |
| K173964 | OVOMotion Shoulder Arthroplasty System | HSD | 2018-04-18 | 110 |
| K172383 | Arthrosurface Bone Screws | HWC | 2017-12-22 | 136 |
| K170440 | KISSloc Suture System | HTN | 2017-05-03 | 78 |
| K170350 | ToeMATE® Hammertoe Correction System | HWC | 2017-03-03 | 28 |
| K162391 | AlignMATE Lapidus Arthrodesis System | HRS | 2017-02-21 | 179 |
| K161539 | Arthrosurface Bone Screws | HWC | 2016-06-30 | 27 |
16 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-11-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Arthrosurface, Inc. have?
Arthrosurface, Inc. has 26 FDA 510(k) clearances (first 2004, latest 2021), across 12 product codes in 1 review panel.
How long does FDA take to clear Arthrosurface, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arthrosurface, Inc.'s cleared 510(k)s is 148 days. Since 2017: 136 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does Arthrosurface, Inc. make?
Its most frequent FDA product codes are KWD (Prosthesis, Toe, Hemi-, Phalangeal, 5); HRS (Plate, Fixation, Bone, 4); HWC (Screw, Fixation, Bone, 4).
Has Arthrosurface, Inc. had device recalls?
openFDA lists 6 product recalls in 2 recall events by a recalling firm whose name matches Arthrosurface, Inc; the most recent began 2014-11-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Arthrosurface, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWD, Arthrosurface, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.