Lumbar Spine Truss System - Plating Solution (LSTS-PS)
FDA 510(k) K253201 · 4Web, Inc.
510(k) numberK253201
Submission
- Device name
- Lumbar Spine Truss System - Plating Solution (LSTS-PS)
- Applicant
- 4Web, Inc.
Frisco, TX, US - Received
- September 26, 2025
- Decision date
- February 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | Alphatec Spine, Inc. | 08/28/2025SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ · Traditional | 03/10/2021SE |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD · Traditional | 05/29/2020SE |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA)OVE · Traditional | 08/12/2019SE |
| K190926 | Hammertoe Truss System (HTS)HTY · Traditional | 07/23/2019SE |
| K172294 | Osteotomy Truss System (OTS)HRS · Traditional | 02/22/2018SE |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/08/2018SE |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX · Traditional | 11/07/2017SE |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX · Traditional | 09/08/2017SE |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX · Traditional | 08/07/2017SE |
| K153436 | LATERAL Spine Truss SystemMAX · Traditional | 06/06/2016SE |
Questions and answers
When was Lumbar Spine Truss System - Plating Solution (LSTS-PS) cleared by the FDA?
Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201) received a 510(k) decision of Substantially Equivalent on February 12, 2026, 139 days after the submission was received.
What is the product code of K253201?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.