Arthropedics, Inc.: FDA clearances and approvals
Arthropedics, Inc. has 29 FDA 510(k) clearances (first 1987, latest 1988), across 12 product codes in 2 review panels. Median 510(k) review time: 63 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HTD | Forceps | 8 | 8 |
| HTS | Knife, Orthopedic | 4 | 4 |
| HRX | Arthroscope | 3 | 3 |
| JOS | Electrode, Electrosurgical | 3 | 3 |
| GEN | Forceps, General & Plastic Surgery | 2 | 2 |
| HRR | Scissors, Orthopedic, Surgical | 2 | 2 |
| HXB | Probe | 2 | 2 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FZS | Curette, Surgical, General Use | 1 | 1 |
| HWB | Extractor | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (17)
- Orthopedic (12)
Most recent Arthropedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873619 | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) | HRX | 1988-01-14 | 128 |
| K873655 | MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 | JOS | 1987-12-15 | 96 |
| K873654 | MONOPOLAR CAUTERY CONICAL TIP #TM-1702 | JOS | 1987-12-15 | 96 |
| K873653 | MONOPOLAR CAUTERY BLADE TIP #TM-1701 | JOS | 1987-12-15 | 96 |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | HXR | 1987-11-25 | 152 |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | HTS | 1987-11-02 | 48 |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | HTS | 1987-11-02 | 48 |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | HTS | 1987-11-02 | 48 |
| K873710 | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | HWB | 1987-11-02 | 48 |
| K873652 | HOOK PROBE #TM-1376 | HXB | 1987-11-02 | 53 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arthropedics, Inc..
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 Arthropedics, Inc. have?
Arthropedics, Inc. has 29 FDA 510(k) clearances (first 1987, latest 1988), across 12 product codes in 2 review panels.
How long does FDA take to clear Arthropedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arthropedics, Inc.'s cleared 510(k)s is 63 days.
What devices does Arthropedics, Inc. make?
Its most frequent FDA product codes are HTD (Forceps, 8); HTS (Knife, Orthopedic, 4); HRX (Arthroscope, 3).
Has Arthropedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Arthropedics, Inc. Related entities may recall under other names.
Next steps
- See all 29 Arthropedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTD, Arthropedics, 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.