Enos Software Guided External Fixation System
ENOS is software that plans patient-specific deformity correction using the Monkey Rings circular external fixation system. It calculates a schedule of strut adjustments from the surgeon's…
ENOS is software that plans patient-specific deformity correction using the Monkey Rings circular external fixation system. It calculates a schedule of strut adjustments from the surgeon’s treatment objectives.
The surgeon enters anatomical alignment measurements and the external frame’s hardware configuration. The algorithm combines these inputs with the mechanical characteristics of the fixation system to calculate the required strut lengths.
Planning Output
The software lets the surgeon visualize the planned bone movement and produces a prescription of adjustments for the compatible frame. Its calculations use manually entered information rather than direct X-ray measurements. The software supports planning; the external fixation hardware performs the physical correction as the prescribed strut changes are made.
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 | Disior OY, Finland |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K253764 |
| Record published | 2026-04-02 |
| Record revised | 2026-06-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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 |
| Orthex External Fixation System | Orthopediatrics, Corp | 1 |
| Smart Correction | Wishbone Medical Inc. | 1 |
| Orthex | Orthopediatrics, Corp | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253764 | 2026-02-26 |
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.