TriLEAP
The FDA summary describes the TRILEAP Plating System as intended for reduction, temporary fixation, fusion and stabilization of bones. The system includes procedure-specific plates,…
The FDA summary describes the TRILEAP Plating System as intended for reduction, temporary fixation, fusion and stabilization of bones.
The system includes procedure-specific plates, cortical screws and variable-angle locking screws in multiple sizes.
Listed Item
1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Degree, Left
Indicated Anatomy
The filing identifies fixation of bones and bone fragments of the foot and ankle for adults and adolescents aged 12 to 21. Plate options range from 2.0 mm through 4.0 mm.
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K230591 |
| Record published | 2025-03-20 |
| Record revised | 2026-01-30 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Deg, Right | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 10 Deg, Right | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 Degree, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 10 Deg, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 0 Deg, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 5 Deg, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 0 Deg, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 0 Deg, Right | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 0 Deg, Right | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 5 Deg, Right | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 5 Deg, Left | In distribution | |
| 1st MTP Ti Fusion Plate, Extra Small, 5 Hole, 5 Deg, Right | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253178 | 2026-01-06 |
| K230591 | 2023-09-29 |
| K223342 | 2023-03-30 |
| K190658 | 2019-04-12 |
| K181872 | 2019-02-19 |
| K160300 | 2016-04-22 |
| K152306 | 2015-12-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.