Guided Growth Plate System
Guided Growth Plate System gradually redirects the growth of long bones in children whose growth plates remain open. A low-profile plate is attached across the outside of the growth plate…
Guided Growth Plate System gradually redirects the growth of long bones in children whose growth plates remain open. A low-profile plate is attached across the outside of the growth plate using two or four screws.
The screws are not locked to the plate and can swivel and diverge as the bone grows. This creates a flexible-hinge effect that guides gradual correction of angular deformity.
Listed Item
Guided growth D.4.5 mm L.32 mm cannulated ss screw full thread, non sterile
Plate Construction
The plates and screws are implant-quality stainless steel. A contoured plate waist suits the pediatric anatomy, and a central hole accepts a temporary guide pin for placement. Eight-Plate and quad-Plate forms provide different plate and screw arrangements for the selected growing bone.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | OBT |
| Device type | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K110805 |
| Record published | 2015-11-10 |
| Record revised | 2025-10-24 (version 9) |
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, manufacturing date, serial number |
| Sizes | Length 12 to 36 mm; outer diameter 2.4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Centre to centre distance 12 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | In distribution | |
| 1 | Centre to centre distance 22 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Centre to centre distance 16 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 24 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 22 mm | In distribution |
| 1 | Centre to centre distance 16 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 2.4 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Centro to centre distance 22 mm | In distribution |
| 1 | Outer Diameter 3.2 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Centre to centre distance 16 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 12 mm | In distribution |
| 1 | Length 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WishFIX | Wishbone Medical Inc. | 248 |
| EpiFIX | Wishbone Medical Inc. | 240 |
| WishFIX | RED Star Contract Manufacturing Inc. | 124 |
| Giro Growth Modulation System | Orthopediatrics Canada ULC | 35 |
| Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180624 | 2018-05-15 |
| K172183 | 2018-01-09 |
| K110805 | 2011-06-21 |
| K093442 | 2010-06-10 |
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.