Solar™ PSI Interbody Fusion System
Solar-S PSI is a patient-specific anterior lumbar interbody spacer for skeletally mature patients with degenerative disc disease from L1 to S1, with up to Grade 1 spondylolisthesis or…
Solar-S PSI is a patient-specific anterior lumbar interbody spacer for skeletally mature patients with degenerative disc disease from L1 to S1, with up to Grade 1 spondylolisthesis or retrolisthesis, after six months of nonoperative treatment. It is filled with autograft or cancellous or corticocancellous allograft bone.
The spacer is additively manufactured from unalloyed titanium using the patient’s imaging data. Its heights, footprint, graft window and angles are individually designed. Integrated fixation uses three screws or three titanium tusks. The implant arrives in its final geometry for surgery.
Listed Item
Solar-S™ PSI Spacer
Fixation Requirements
With three screws and lordosis of 20 degrees or less, Solar-S can be used standalone at one or two contiguous levels. Tusks or lordosis above 20 degrees require supplemental fixation. With supplemental fixation, the device may be used at one or more levels.
Who Else Makes It
Concentrated in Shandong (2), 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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Degen Medical, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K241077 |
| Record published | 2024-11-13 |
| Record revised | 2025-07-14 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-11T | In distribution | |
| 1715 | In distribution | |
| 1713 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251829 | 2025-12-08 |
| K241077 | 2024-10-29 |
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.