Sternal Cable System
The Sternal Cable System closes and stabilizes the sternum after sternotomy. Multistrand cables and crimps form cerclage constructs around the bone; a tensioner/crimper tensions the cables…
The Sternal Cable System closes and stabilizes the sternum after sternotomy. Multistrand cables and crimps form cerclage constructs around the bone; a tensioner/crimper tensions the cables and secures the crimps. Multiple figure-eight constructs provide stabilization together.
Cables are supplied with a preassembled needle and leader to assist placement. These nonimplantable parts are removed before wound closure. The filed stainless steel pack with four cables and mixed needle types is one configuration within the family.
Listed Item
SS 3 Tapered Cutting & 1 Reverse Cutting Needle, 4 Cables PER Pouch
Materials and Supply
Cable options use Ti-6Al-4V ELI titanium alloy or 316L stainless steel. Matching crimps use commercially pure titanium or 316L stainless steel; the corresponding metal systems are kept separate. Implants are gamma sterilized for single use. Reusable instruments are supplied nonsterile for steam sterilization, with cases for instrument transport and processing.
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 | A & E Medical Corporation, United States |
|---|---|
| FDA product code | JDQ |
| Device type | Cerclage, Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| 510(k) | K193479 |
| Record published | 2025-04-21 |
| Record revised | 2025-05-30 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-690 | In distribution | |
| 400-890 | In distribution | |
| 408-720 | In distribution | |
| 408-722 | In distribution | |
| 401-020 | In distribution | |
| 400-413 | In distribution | |
| 400-727 | In distribution | |
| 400-425 | In distribution | |
| 408-719 | In distribution | |
| 400-411 | In distribution | |
| 408-723 | In distribution | |
| 400-427 | In distribution | |
| 402-618 | In distribution | |
| 400-689 | In distribution | |
| 401-096 | In distribution | |
| 402-523 | In distribution | |
| 400-401 | In distribution | |
| 408-721 | In distribution | |
| 402-522 | 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 |
| Compression Screw System | Biomet Orthopedics | 18 |
| Accord | Smith & Nephew, Inc. | 15 |
| Cable-Ready® | Zimmer, Inc. | 14 |
| Arthrex® | Arthrex, Inc. | 10 |
| Stitch Cerclage – Suture Tapes | GM DOS Reis Industria E Comercio Ltda | 10 |
Showing 12 of 56. All products under Cerclage, Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193479 | 2020-03-23 |
| K181607 | 2018-10-12 |
| K180582 | 2018-05-31 |
| K173579 | 2018-02-12 |
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.