Atec Solus
The Alphatec Solus lumbar spacer supports anterior lumbar interbody fusion in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1.…
The Alphatec Solus lumbar spacer supports anterior lumbar interbody fusion in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1. Patients may have up to Grade I spondylolisthesis or retrolisthesis and should have received six months of nonoperative treatment.
The implant combines a PEEK cage, titanium anchoring blades and tantalum markers for radiographic visualization. Two internal fixation blades sit within the cage and are separated by a C-ring. Different implant heights and lordotic angles accommodate patient anatomy.
Listed Item
ALPHATEC SOLUS LUMBAR SPACER, 16mm MEDIUM, 7° LORDOTIC, STERILE
Required Fixation
Use requires autograft and supplemental spinal fixation in addition to the integrated blades. Compatible systems include Alphatec Zodiac, Aspida, ILLICO MIS, ILLICO FS or BridgePoint fixation systems.
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 | Alphatec Spine, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123993 |
| Record published | 2015-08-31 |
| Record revised | 2022-12-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Angle 7 °; height 10 to 18 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25200-116-S | Angle 7 ° | In distribution |
| 25600-118-S | Angle 7 ° | In distribution |
| 25600-110-S | Angle 7 ° | 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 |
|---|---|
| K251575 | 2025-09-03 |
| K232097 | 2023-09-25 |
| K203742 | 2021-04-09 |
| K123993 | 2013-03-05 |
| K102402 | 2011-03-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-26 | Class II | Device Design | Due to reports of intraoperative graft bolt implantation breakages. | 12,777 devices |
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.