CrossRoads Screw System
FDA 510(k) K152072 · Crossroads Extremity Systems, LLC
510(k) numberK152072
Submission
- Device name
- CrossRoads Screw System
- Applicant
- Crossroads Extremity Systems, LLC
Memphis, TN, US - Received
- July 27, 2015
- Decision date
- September 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253178 | TRILEAP Plating SystemHRS · Traditional | 01/06/2026SE |
| K241050 | CrossRoads Modular Tray SystemKCT · Traditional | 07/16/2024SE |
| K230591 | TriLEAP Plating SystemHRS · Traditional | 09/29/2023SE |
| K223342 | MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET…HRS · Traditional | 03/30/2023SE |
| K220797 | FootHold SystemMBI · Traditional | 04/15/2022SE |
| K202268 | CrossRoads Tray SystemKCT · Traditional | 12/30/2020SE |
| K190658 | MIS Bunion Plating SystemHRS · Special | 04/12/2019SE |
| K181872 | MIS Bunion SystemHRS · Traditional | 02/19/2019SE |
| K181866 | MotoCLIP/HiMAX Step Staple Implant SystemJDR · Special | 08/09/2018SE |
| K181410 | MotoCLIP/HiMAX Implant SystemJDR · Special | 06/29/2018SE |
Questions and answers
When was CrossRoads Screw System cleared by the FDA?
CrossRoads Screw System (K152072) received a 510(k) decision of Substantially Equivalent on September 23, 2015, 58 days after the submission was received.
What is the product code of K152072?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.