VariTrax Sternal Circumfixator Sternal Plate
The VariTrax Sternal Circumfixator Sternal Plate is the buttress component of a fixation system for closing or repairing the sternum after sternotomy or fracture. Used with matching locking…
The VariTrax Sternal Circumfixator Sternal Plate is the buttress component of a fixation system for closing or repairing the sternum after sternotomy or fracture. Used with matching locking bands, it stabilizes the sternum to support fusion during primary or secondary repair.
The plate is made from polyetheretherketone, or PEEK. VariTrax bands pass around the sternum through the intercostal spaces, then attach and lock to the plate. Tightening and securing the bands completes the fixation construct.
Listed Item
VariTrax Sternal Circumfixator Sternal Plate, 178 mm
Band Placement
The bands use detachable stainless steel needles for placement; the needles are removed before the bands are locked to the plate. The system’s implants are provided sterile and are intended for single use.
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Circumfix Solutions, Inc, United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K232986 |
| Record published | 2025-10-17 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CFSP-0178S | In distribution | |
| CFSP-0142S | In distribution | |
| CFSP-0166S | In distribution | |
| CFSP-0154S | In distribution | |
| CFSP-0186S | In distribution | |
| CFSP-0130S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cerclage, Fixation | Synthes Gmbh | 102 |
| Optilink | Synthes Gmbh | 61 |
| Songer® Spinal Cable System | Pioneer Surgical Technology, Inc. | 60 |
| DePuy Songer Spinal Cable System | Pioneer Surgical Technology, Inc. | 36 |
| Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 34 |
| Dall-Miles | Howmedica Osteonics Corp | 22 |
| Sternal Cable System | Pioneer Surgical Technology, Inc. | 20 |
| Sternal Cable System | A & E Medical Corporation | 19 |
| Compression Screw System | Biomet Orthopedics | 18 |
| Accord | Smith & Nephew, Inc. | 15 |
| Cable-Ready® | Zimmer, Inc. | 14 |
| Arthrex® | Arthrex, Inc. | 10 |
Showing 12 of 56. All products under Cerclage, Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232986 | 2024-01-30 |
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.