TriMed, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “TriMed, Inc.” (first 2005, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 60 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 227 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 217 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 151 |
| 2020 | 1 | 101 |
| 2021 | 1 | 58 |
| 2022 | 2 | 99 |
| 2023 | 2 | 96 |
| 2024 | 4 | 68 |
| 2025 | 10 | 70 |
| 2026 | 4 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name TriMed, Inc. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 25 | 25 |
| HWC | Screw, Fixation, Bone | 7 | 7 |
| HTN | Washer, Bolt Nut | 2 | 2 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| NDK | System, External Fixator (With Metallic Invasive Components) | 1 | 1 |
Review panels
- Orthopedic (38)
Most recent TriMed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262344 | Large Compression Screws | HWC | 2026-08-12 | 33 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | HRS | 2026-07-16 | 29 |
| K261241 | TriMed Compression Screws | HWC | 2026-05-14 | 29 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | HRS | 2026-01-15 | 31 |
| K252061 | Distal Xtremities System | HRS | 2025-08-20 | 50 |
| K251134 | RipCord | HTN | 2025-07-11 | 91 |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | HRS | 2025-07-10 | 15 |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | HRS | 2025-06-26 | 90 |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | HRS | 2025-05-22 | 55 |
| K243943 | TriMed® Compression Screws | HWC | 2025-04-10 | 111 |
28 earlier clearances. See the full list in Caduvo.
Recalls
19 product recalls in 11 recall events; 4 initiated in the last five years. Most recent: 2024-03-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Trimed Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under TriMed, Inc.?
FDA lists 38 510(k) clearances under the applicant name “TriMed, Inc.” (first 2005, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by TriMed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name TriMed, Inc. is 86 days. Since 2017: 60 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under TriMed, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 25); HWC (Screw, Fixation, Bone, 7); HTN (Washer, Bolt Nut, 2).
Next steps
- See all 38 TriMed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, TriMed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.