Crossroads Extremity Systems, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Crossroads Extremity Systems, LLC” (first 2015, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 90 days, against 92 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 |
|---|---|---|
| 2015 | 3 | 114 |
| 2016 | 2 | 92 |
| 2017 | 0 | — |
| 2018 | 3 | 30 |
| 2019 | 2 | 126 |
| 2020 | 1 | 141 |
| 2021 | 0 | — |
| 2022 | 1 | 28 |
| 2023 | 2 | 180 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 1 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Crossroads Extremity Systems, LLC took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 7 | 7 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
Review panels
- Orthopedic (14)
- General Hospital (2)
Most recent Crossroads Extremity Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253178 | TRILEAP Plating System | HRS | 2026-01-06 | 102 |
| K241050 | CrossRoads Modular Tray System | KCT | 2024-07-16 | 90 |
| K230591 | TriLEAP Plating System | HRS | 2023-09-29 | 210 |
| K223342 | MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System | HRS | 2023-03-30 | 149 |
| K220797 | FootHold System | MBI | 2022-04-15 | 28 |
| K202268 | CrossRoads Tray System | KCT | 2020-12-30 | 141 |
| K190658 | MIS Bunion Plating System | HRS | 2019-04-12 | 29 |
| K181872 | MIS Bunion System | HRS | 2019-02-19 | 222 |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | JDR | 2018-08-09 | 28 |
| K181410 | MotoCLIP/HiMAX Implant System | JDR | 2018-06-29 | 30 |
6 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-09-19.
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.
- Crossroads Extemity Systems, LLC (3 510(k)s)
- Crossroads Neurovascular, Inc. (2 510(k)s)
- Crossroads Distribution Company, LLC (1 510(k)s)
- Crossroads Trading Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Crossroads Extremity Systems, LLC?
FDA lists 16 510(k) clearances under the applicant name “Crossroads Extremity Systems, LLC” (first 2015, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Crossroads Extremity Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Crossroads Extremity Systems, LLC is 96 days. Since 2017: 90 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Crossroads Extremity Systems, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 7); HWC (Screw, Fixation, Bone, 3); JDR (Staple, Fixation, Bone, 2).
Next steps
- See all 16 Crossroads Extremity Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Crossroads Extremity Systems, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.