Paradigm
Paradigm is the listed name for Proprio’s Paradigm System. The FDA filing describes a stereotaxic image guidance system for spatial positioning and orientation of spinal surgical…
Paradigm is the listed name for Proprio’s Paradigm System. The FDA filing describes a stereotaxic image guidance system for spatial positioning and orientation of spinal surgical instruments.
The filing indicates use by surgeons during open posterior approach spine surgery for pedicle screw cannulation from the thoracic to sacrum vertebrae, using a rigid anatomical reference identifiable on CT-derived patient images.
Listed Item
Surgical Instrument Set for Paradigm System
Device Function and Details
The system combines real-time camera imaging of the surgical site with medical imagery and navigation data. Preoperative CT data is used to generate a 3D model; intraoperative imaging registers exposed anatomy to that model.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), 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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Proprio, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K243258 |
| Record published | 2025-03-21 |
| Record revised | 2025-05-20 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Crate |
| Distribution end date | 2025-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1200019 | In distribution | |
| 1200013 | In distribution | |
| 1200010 | In distribution | |
| 1300001 | In distribution | |
| 1200017 | In distribution | |
| 1200006 | In distribution | |
| 1100004 | In distribution | |
| 1200008 | In distribution | |
| 1200004 | In distribution | |
| 1200014 | In distribution | |
| 1200018 | In distribution | |
| 1200012 | In distribution | |
| 1200009 | In distribution | |
| 1200003 | In distribution | |
| 1200005 | In distribution | |
| 1200007 | In distribution | |
| 1200015 | In distribution | |
| 1200029 | In distribution | |
| 1100006 | In distribution | |
| 1200016 | In distribution | |
| 1200011 | In distribution | |
| 1200002 | Withdrawn | |
| 1200001 | Withdrawn | |
| 1100001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252950 | 2025-12-15 |
| K250879 | 2025-06-04 |
| K243258 | 2025-02-21 |
| K222291 | 2023-04-21 |
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.