PediatrOS™ RigidTack™
PediatrOS RigidTack is a titanium-alloy bone staple used to correct leg-length discrepancy through epiphysiodesis in growing children and adolescents. Its trapezoidal shape fits the…
PediatrOS RigidTack is a titanium-alloy bone staple used to correct leg-length discrepancy through epiphysiodesis in growing children and adolescents. Its trapezoidal shape fits the epiphyseal region, and a support strut provides rigid mechanical behavior.
Jagged staple legs help secure fixation in bone. Cannulated legs permit placement over K-wires, while internal threads support removal using threaded wires and appropriate explantation instruments.
Growth Modulation
The staples act at the growth plate to inhibit longitudinal growth, with different sizes accommodating patients before skeletal maturity. The broader PediatrOS range addresses angular deformity and limb-length discrepancy; RigidTack provides the rigid staple configuration.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 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 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Merete Gmbh, Germany |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K151762 |
| Record published | 2016-02-29 |
| Record revised | 2025-06-20 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 20 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30 | Length 30 mm | In distribution |
| 25 | Length 25 mm | In distribution |
| 20 | Length 20 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151762 | 2015-12-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merete Gmbh | 510(k) number | 2022-01-18 | Class II | Error in labeling | Incorrect marketing label (25 mm) was applied to product size 20 mm. | 26 units | 2023-02-16 |
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.