SDS Growing Rod
SDS Growing Rod is a spinal implant system designed to correct early-onset deformity while allowing spinal growth. Its construct combines one or two springs with sliding bearings and 5.5 mm…
SDS Growing Rod is a spinal implant system designed to correct early-onset deformity while allowing spinal growth. Its construct combines one or two springs with sliding bearings and 5.5 mm rods.
The spring supplies distraction force, while the bearing allows one rod to move relative to the other as growth occurs. Hybrid and bilateral configurations are available. Titanium-alloy spring and bearing components use polyethylene bushings or bearings, alongside cobalt-chromium rods.
Listed Item
Torque Limiting Handle 9Nm
Implantation and Treatment
The implant is supplied sterile for single use and is removed or locked when treatment is complete. Dedicated instruments include a spring compressor, spring locker, C-Clamp forceps and 9 Nm torque-limiting handle. Compatible fixation components must preserve the sliding and spring mechanisms.
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Record
| Listed by | Baat Medical Products B.V., Netherlands |
|---|---|
| FDA product code | PGM |
| Device type | Growing Rod System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K251961 |
| Record published | 2026-03-30 |
| Record revised | 2026-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The products shall be stored and handled with care. The packaging shall remain intact at all times. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution | |
| SDS Growing Rod | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VerteGlide Spinal Growth Guidance System | Orthopediatrics, Corp | 204 |
| CD Horizon® Growth Rod Conversion Set | Medtronic Sofamor Danek, Inc. | 37 |
| Shilla™ Growth Guidance System | Medtronic Sofamor Danek, Inc. | 23 |
| Daytona® Small Stature | Seaspine Orthopedics Corporation | 8 |
| Expedium | Depuy Spine, Inc. | 6 |
| MSB Shilla Growth Guidance System | Medtronic Sofamor Danek, Inc. | 5 |
| XIA | Stryker GmbH | 4 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251961 | 2026-01-15 |
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.