Orthex
Orthex P&C Software v1.2
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (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 |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| YU XIN Technology(Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151881 |
| Record published | 2020-02-28 |
| Record revised | 2026-06-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORTHEXRPS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Software For Diagnosis/Treatment | Synthes Gmbh | 108 |
| Maxframe | Synthes Gmbh | 27 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Maxframe | Synthes (U.S.A.) LP | 5 |
| Acute QC Strut and Components | Smith & Nephew, Inc. | 5 |
| True Lok System | Orthofix SRL | 3 |
| Smart TSF | Smith & Nephew, Inc. | 3 |
| Orthex | Vilex IN Tennessee, Inc. | 1 |
| Enos Software Guided External Fixation System | Disior OY | 1 |
| Orthex External Fixation System | Orthopediatrics, Corp | 1 |
| Smart Correction | Wishbone Medical Inc. | 1 |
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 |
|---|---|---|---|---|---|---|
| Orthopediatrics, Corp | 510(k) number | 2022-09-12 | Class II | Under Investigation by firm | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. | 1354 (594 US) |
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.