Osteotomy Truss System (OTS)
FDA 510(k) K172294 · 4Web, Inc.
510(k) numberK172294
Submission
- Device name
- Osteotomy Truss System (OTS)
- Applicant
- 4Web, Inc.
Frisco, TX, US - Received
- July 31, 2017
- Decision date
- February 22, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 02/12/2026SE |
| 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 |
| 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 Osteotomy Truss System (OTS) cleared by the FDA?
Osteotomy Truss System (OTS) (K172294) received a 510(k) decision of Substantially Equivalent on February 22, 2018, 206 days after the submission was received.
What is the product code of K172294?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.